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 Table of Contents

3 18
3 Review of FDA Sunscreen Regulations
by Nadim Shaath

11 Skin Damage Caused by UV

by Paolo Giacomoni

16 The Ultimate Protection for Sun Protection

by schülke

18 What Lies Beneath:

Reef-Safe Sunscreen Formulas
by Happi Editorial Staff

21 New Product Review

by Happi Editorial Staff

24 Head Toward the Light

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 Feature Headline
Feature Deck

First Last • Title

Sunscreen Regulations
in the US
The US Food and Drug Administration’s goal to finalize the Sunscreen
Monograph by November 26, 2019 is totally unrealistic—here’s why.

Nadim A. Shaath, PhD • Alpha Research & Development

T
he Over-The-Counter (OTC) Drug Review is the pro-
cess established by the United States Food and Drug
Administration (FDA) to evaluate the safety and effective-
ness of OTC drug products marketed in the US before May 11,
1972. It also established the conditions under which OTC drug
products are considered Generally Regarded as Safe and Effective
(GRASE) and not misbranded. Ultraviolet filters are then classi-
fied into three categories:
Category I – GRASE items (permitted at levels specified)
Category II – Non-GRASE items (not permitted for use
in sunscreens)
Category III – Requiring additional safety data prior to use.
The ultimate goal when this rule-making process is complet-
ed by the FDA is the establishment of a final monograph for sun
care OTC therapeutic drug category.
The call for safety and efficacy data for sunscreen products
was issued on December 12, 1972 (37 FR 26456) and the resulting
data submission were reviewed by an Advisory Review Panel on
OTC Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn
Prevention and Treatment Products. A recommended monograph
was published as an Advance Notice for Public Record (ANPR)
on August 25, 1978 (43 FR 38206). The ANPR listed 21 sunscreen
active ingredients that were classified as GRASE (Category I)
under the conditions described in the panel’s report (see Table
I). Fifteen years later, on May 12, 1993, the FDA published a

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 SUNSCREEN REGULATIONS IN THE US

Tentative Final Monograph (TFM) (58 FR 28194) which excluded Table II: FDA Approved Ultraviolet Filters in 1999
padimate-A and approved the remaining 20 ultraviolet filters as
GRASE at specified maximum concentrations. Active Ingredient Maximum Concentration (%)

Table I: FDA Approved Ultraviolet Filters in 1993 Aminobenzoic acid (PABA) 15

Avobenzone 3
UVA absorbers/reflectors % Cinoxate 3
Oxybenzone 2-6 Dioxybenzone 3
Sulisobenzone 5-10 Ensulizole 4
Dioxybenzone 3 Homosalate 15
Menthyl anthranilate 3.5-5 Meradimate 5
Red petrolatum 30-100 Octinoxate 7.5
Titanium dioxide 2-25 Octisalate 5
UVB Absorbers Octocrylene 10
Aminobenzoix acid 5-15 Oxybenzone 6
Amyl dimethyl PABAa 1-5 Padimate O 8
2-Ethoxyethyl p-methoxycinnamate 1-3 Sulisobenzone 10
Diethanolamine p-methoxycinnamatea 8-10
Titanium dioxide 25
Digalloyl trioleatea 2-5
Trolamine salicylate 12
Ethyl 4-bis(hydroxypropyl) aminobenzoatea 1-5
Zinc oxide 25
2-Ethylhexyl-2-cyano-3,3-diphenyl-acrylate 7-10
Ethylhexyl p-methoxycinnamate 2-7.5
1999, the FDA published its Time and Extent Application (TEA)
2-Ethylhexy salicylate 3-5
Regulations (67 FR 3060) on Jan. 23, 2002. The TEA regulation sets
Glyceryl aminobenzoatea 2-3
forth criteria by which OTC drugs without any US marketing ex-
Homomenthyl salicylate 4-15
perience, but with extensive safe foreign use, can be considered
Lawsone with Dihydroxyacetonea 0.25 for inclusion in the OTC drug monograph system. The FDA sug-
Octyl dimethyl PABA 1.4-8 gested that this process would allow manufacturers a maximum of
2-Phenylbenzimidazole-5-sulfonic acid 1-4 a year for inclusion into the monograph system if all requirements
Triethanolamine salicylate 5-12 of the FDA were met. Unfortunately, this process took years (in
excess of 10 years in some cases) without any FDA approvals. This
a
These items have been deleted in the Final Monograph in 1999. Three ad-
prompted a group of dermatologists, scientists, health advocates
ditional items have been added since, namely, avobenzone (1-3 %), ecamsule
(up to 10 %), and zinc oxide (2-25 %)
and sunscreen manufacturers to form a coalition that would lobby
Congress for the swift passage of those sorely needed TEA ingre-
dients—many were very effective UVA protecting ingredients with
In 1999 the FDA published a final sunscreen monograph at least a 10-year history of continued use in Europe and other
which now has listed only 16 ultraviolet filters as GRASE at the countries. The Public Access to Safe Sunscreens (PASS) Coalition
specified maximum concentrations (Table II). was headquartered in the offices of a law firm in Washington DC.
This 1999 Final Monograph was“stayed”on December 31, 2001 The successful efforts of the PASS Coalition resulted in Congress
(66 FR 678185) and to date, no Final Monograph has been issued. passing the Suncare Innovation Act (SIA) that was signed by
In 2011 the FDA published a draft guidance for industry President Barack Obama on Nov. 26, 2014. The SIA set a limit of
“Enforcement Policy-OTC Sunscreen Drug Products Marketed five years for the finalization of the Sunscreen Monograph mark-
without an Approved Application.” This guidance which ad- ing Nov. 26, 2019 as the final date for the FDA to finalize its sun-
dressed the circumstances under which the FDA intended to screen regulations.
exercise its enforcement discretion until a Final OTC Sunscreen With this deadline of November 2019 looming on the hori-
Monograph is issued, was finalized in May 2018.1 With this zons, the FDA issued on Feb. 26, 2019 its proposed rule to put in
guidance the FDA would not object to the marketing of OTC effect a Final Monograph for non-prescription, over-the-coun-
sunscreen products that do not have an approved New Drug ter (OTC) sunscreen drug products by Nov. 26, 2019. This pro-
Application (NDA) or Amended NDA so long as they are in com- posed rule describes the conditions by which the FDA proposes
pliance with the conditions of the 1999 Final Monograph. that OTC sunscreen monograph products would be GRASE and
After the publication of the Final Sunscreen Monograph in not misbranded.2

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The highlights of the 2019 Proposed Rule are as follows:
1. Proposed GRASE status of active ingredients listed
in the stayed 1999 Final Monograph. According to the FDA,
only zinc oxide and titanium dioxide (at concentrations of up to
25%) are GRASE and Category I ingredients. Two other ingre-
dients, namely PABA and trolamine salicylate, were classified as
Category II; i.e., can no longer be used in sunscreen products.
The FDA proposed that the remaining 12 ingredients be classified
as Category III; i.e., require further testing prior to approval as
Category I. The FDA acknowledges that all 12 of these UV filters
have limited data—or no data—characterizing their skin absorp-
tion. It specifically singled out oxybenzone as being absorbed
through the skin to a greater extent than previously understood.
2. Proposed Requirements Related to Dosage Forms. In
2011, the FDA published an Advanced Notice of Proposed Rule
Making (ANPR) identifying sunscreen dosage forms. This new
2019 proposal identifies the following dosage forms as Category
I:“oils, lotions, creams, gels, butters, pastes, ointments and sticks.”
As for “sprays” they would be considered Category I subject to
further testing necessary to minimize potential risks from unin-
tended inhalation (particle size restrictions), flammability, drying
time testing and related labeling requirements. The FDA propos-
es to classify “powders” as Category III and that sunscreens in all
other dosage forms, including “wipes, towelettes, body wash and
shampoos,” are new drugs because the FDA did not receive data
showing that they were marketed prior to 1972, as required for
inclusion in the monograph.
3. Proposed Maximum SPF and Broad-Spectrum Require-
ments. The 1978 ANPR set SPF 15 as the maximum labeled SPF
value, the 1999 Final Monograph (now stayed) established SPF
30+ as the maximum labeled SPF value and subsequently in 2011
raised the value to 50+. In this Proposed Rule (2019) the maxi-
mum allowed will be an SPF of 60+. FDA also proposes to permit
the marketing of SPF values up to 80 and would allow sunscreen
products with SPF values above 80 with an approved NDA. The
FDA has raised concerns about the potential for inadequate UVA
protection—particularly in high SPF sunscreen products. To ad-
dress these concerns, FDA proposed that all sunscreen products
with SPF values of 15 and above satisfy broad spectrum require-
ments and meet UVAI/UV ratio of 0.7 or higher. Finally, FDA is
proposing that testing at SPF 30 or more be labeled in increments
of 10; i.e., SPF 30, 40, 50 and 60+; and sunscreen testing at SPF
15 to 29 be labeled in increments of 5; i.e., SPF 15, 20 25; and no
ranges are required for SPFs below 15.
4. Proposed PDP Labeling Requirements. A major feature
of the Principal Display Panel is the Statement of Identity (SOI).
The FDA proposes that the SOI consist of alphabetical listing of
the sunscreen active ingredients in the product, followed by“sun-
screen” and the product’s dosage form, such as lotion or spray.
Other changes to the format of the PDP are also proposed.
5. Proposed Requirements Related to Final Formulation
Testing Process and Record Keeping. The FDA is proposing to
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SUNSCREEN REGULATIONS IN THE US
require records of the testing of sunscreen products to be main-
tained for one year after three years from the distribution of the
last lot of the product. Other revisions will be also be required.
6. Proposed Status of Sunscreen/Insect Repellent
Combination Products. The FDA proposes to classify these
products as Category II because of incompatibilities between
FDA and EPA labeling requirements.
7. Proposed Actions to Effectuate Lifting of Stay and
Harmonize Impacted Regulations. The FDA proposes lifting
the stay on the 1999 Final Monograph subject to the revision of
this proposed Final Rule.
Comments and Observations
The new 2019 FDA Sunscreen Regulations Proposal is a “well
written” and “thorough” document.2 It is, however, at least five
years too late, as the long wait and the uncertainty in regula-
tions have put a major damper on our efforts to seek newer, safer
and more effective UV filters. Their approval would have allowed
cosmetic and sunscreen chemists to create superior formulations
that better protect consumers. Today we have a rag-tag collec-
tion of UV filters that the current FDA proposal has deemed all
but two (zinc oxide and titanium dioxide) as Category I GRASE
filters to use. Two others, trolamine salicylate and PABA, were
banned and relegated to Category II (non-GRASE items) and the
remaining 12 filters were classified as Category III filters requiring
extensive safety data before being reapproved. Fortunately, the
FDA is allowing their use in current formulations until the Final
Regulations become effective on November 26, 2019. However,
the FDA released a second document which explained its evalu-
ation of the economic impact of the proposed regulation and
indicated that if industry was willing to provide the safety data
required, FDA would implement a five-year stay on the organic
UV filters which have been proposed to be listed as category III.
The FDA expects that industry will defend 6 of the 12 filters (oxy-
benzone, octinoxate, avobenzone, octisalate, homosalate and oc-
tocrylene). This is unlikely to happen but is under debate within
the industry.
What are the salient features of the proposal?
The deadline that the FDA set, November 26, 2019, was
imposed by the Sunscreen Innovation Act (SIA) that the PASS
Coalition successfully lobbied for in Congress, and the law was
signed by President Obama on Nov. 26, 2014. The SIA set a five-
year maximum timeline for Final Regulations in Sunscreens to
be enacted.
I would have preferred that sunscreens be treated as special
cosmetics, as they are regulated in most of the rest of the world,
and not as OTC drugs. If sunscreens were regulated as cosmetics,
we would have had by now an efficient set of safe and effective
ultraviolet filters that would have afforded our consumers much
better protection particularly from the now well-documented
harmful UVA radiation. That decision, apparently, is not forth-
coming soon as the FDA is reluctant to allow the reclassification
4/10/19 1:42 PM
 SUNSCREEN REGULATIONS IN THE US
of sunscreens as “cosmetics” even though they are mandated to
enforce cosmetic regulations. This new FDA proposal failed to
comment on the status of the six TEA UV filters that we sorely
need. Several of those TEA ingredients are excellent UVA filters
with great safety and repeated use records, and these ingredients
were designed in compliance with the Dalton 500 Rule that mini-
mizes skin penetration. But the FDA is requesting the same type
of additional safety data for the TEA candidates as well, so we are
years away from getting these approved.
The new FDA proposal has a multitude of new regulations that
have been thrust upon the industry with major consequences for
the future of sunscreens and that of skin cancer prevention. What
follows is my review of the main issues in the FDA Proposal.
Proposed GRASE status of active ingredients
At a time when the industry is fending off the barrage of criti-
cism leveled at oxybenzone (I am not a fan of this ingredient)
for destroying coral reefs, the FDA clearly questioned the“human
safety”profile of this ingredient, citing excessive permeability into
the skin and even its endocrine disrupting potential. The state of
Hawaii; the island of Palau; Key West, Florida and others have
passed ordinances banning oxybenzone and octinoxate from use
in sunscreen products, mostly for environmental concerns. But
by questioning their “human safety,” FDA has doomed their ap-
proval as Category I ingredients in the future.
The US sunscreen industry has been relying on the “archaic”
Category I filters (12 of the remaining 16 filters are now Category
III requiring extensive safety testing before they can be classi-
fied as Category I) to formulate all of their sunscreen products.
The FDA’s intransigence by not allowing any new filters to be
introduced into the US market and setting unrealistic barriers
and standards, has discouraged basic research for the creation
of new filters. Today, the sunscreen industry does not have one
“patented” active ingredient on this list of 12 filters that a single
company can afford to spend the money and time required to
establish its safety and satisfy the FDA’s requirements for approv-
al. Which company today is going to submit data that include
the Maximum Usage Trial (MUsT) test for skin permeability, the
Developmental and Reproductive Toxicity (DART) tests for endo-
crine disrupting activities and any other FDA requests to satisfy
the drug requirements of those filters? These filters are currently
sold by numerous vendors, not just one, and their sale to the in-
dustry is, at best, only in the millions to low tens of millions of
dollars annually. They are not cancer-treatment drugs or blood
pressure reducing medicines or cholesterol modifying drugs that
sell for hundreds of millions or billions of dollars a year. The re-
turn on investment is simply not there.
I agree with the premise that dermal permeability testing
(MUsT test or equivalent) should be performed on all current
and future UV filters, all 12 currently characterized as category III
ingredients would fail the test as they are low molecular weight
compounds that would inevitably permeate the skin to one
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degree or another. The solution? Approve the TEA ingredients
that have high molecular weights (based on the Dalton 500 rule)
and encourage the introduction of other novel filters emanating
from research in academia and industry.
The new FDA proposal approved as GRASE (Category I) only
zinc oxide and titanium dioxide. It focused on two other Category
III ingredients, namely oxybenzone and avobenzone. The FDA
is requiring extensive MUsT and DART testing at a minimum
for both avobenzone and oxybenzone. I presume the remain-
ing items, cinoxate, dioxybenzone, sulisobenzone, padimate O,
meradimate, ensulizole, homosalate, octisalate, octinoxate and
octocrylene, would be rendered useless or unapproved if no com-
pany in our industry has the will, the courage, the time and the
money to go through with the proposed extensive testing for ap-
proval as GRASE UV filters. If a gallant company comes forward
and submits the necessary FDA safety data, what will prevent an-
other supplier that did not foot this huge testing bill from selling
those ingredients on the market once approved by the FDA for a
much lower price and gain a competitive advantage?
It is my belief, that the FDA has jumped the gun by throwing
this monkey wrench into industry regulations without at least ap-
proving alternative filters (such as the TEA, or other new ingredi-
ents) that would fill in the gap temporarily to achieve the desired
UV protection. The consumer is bound to question the safety of
those 12 Category III filters, as the FDA has done, and calls for
their removal from our current formulations will undoubtedly be
heard soon.
Proposed Maximum SPF and Broad-Spectrum Requirements
The FDA has acquiesced to industry sunscreen manufacturers’
demands to increase the upper limit of labeled SPF on sunscreen
products. It is ironic, but the FDA has doubled the SPF cap exactly
every 20 years. In 1978 FDA set the upper limit at 15. FDA dou-
bled it in 1999 to 30+. Now, in 2019, the cap has been raised to
60+. In fact, the FDA has indicated that it will consider the mar-
keting of sunscreen products set as high as 80! FDA’s justification
is based, among other considerations, upon the fact that when
testing for the SPF 60 cap, the error in the calculations is about
30%, hence the value of 80! FDA reported several studies that
justified its call for higher SPF products, including several studies
for “at-risk” populations. These included Ulrich et al.’s research
on protection for organ transplant recipients who are susceptible
to non-melanoma skin cancers,3 Kuhn et al. showing prevention
of skin lesions in topical lupus erythmatosis patients,4 Faurschou
et al.’s reporting the prevention of urticarial reactions in subjects
with idiopathic solar urticarial5 and Fourtanier et al.’s work show-
ing lower levels of polymorphous light eruption.6 Thus, for the
vast majority of sunscreen users, those that are not transplant
recipients, do not have lupus erythematosus or idiopathic solar
urticaria or polymorphous light eruptions, will now be subjected
to SPF products with up to a value of 80, loaded with possibly
re-approved Category III ingredients or simply formulations with
April 2019
4/10/19 1:42 PM
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happi • 7
4/10/19 1:42 PM
 SUNSCREEN REGULATIONS IN THE US
only zinc or titanium oxides. All the previous arguments we heard
for not raising the cap to more than 50+ were not considered, in-
cluding international harmonization (the rest of the world has set
50+ as the cap), insufficient data warranting products higher than
50+, the false sense of protection for using SPFs higher than 50
and staying much longer in the sun, and the unnecessary expo-
sure to more UV active ingredients, especially the now-dreaded
so-called chemical UV filters. Those arguments have unfortu-
nately been ignored!
The FDA acknowledges “variability in SPF values is exac-
erbated at high SPF” yet it looks like higher than SPF 50+ will
be the norm in the future of sunscreens. In response, the FDA
has introduced the so-called stricter requirements for measuring
broad spectrum and UVA protection.
The last question that I pose in defense of lower caps, rather
than higher SPF caps, is: how on Earth are we to achieve aes-
thetically-pleasing, low-cost, mass-marketed beach products of
mandated higher SPFs and more efficient UVA protection with
only zinc oxide and titanium dioxide?
Other sweeping changes in the proposal include regulating
the labeling of SPF products according to the following table:
Proposed SPF labeling Range
SPF values below 15 are not regulated and can be any determined
value below 15. SPF values between 15 and 30 increases by 5 SPF
increments. Finally, SPFs above 30 increase by 10 SPF increments.
No other integers are allowed on the product. This will obviously
remove some of the confusion to the consumer.
Ultraviolet A and Broad-Spectrum Protection
In all fairness, the FDA has emphasized that broad spectrum
and UVA claims are paramount especially in high SPF products
(SPF 15 or less products are exempt). A new testing protocol for
UVA protection has been proposed. In its proposed rule, the FDA
introduces UVA I/UV ratio calculation in addition to the critical
wavelength requirement to address broad spectrum protection
of a sunscreen product. Proposed FDA Rule claims that all sun-
screen products should have an in-vivo SPF protection 15 and
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above, critical wavelength 370nm and above as well as a UVA I/
UV Ratio of at least 0.7, and providing “a more uniform amount
of radiation protection across the UVA I, UVA II and UVB ranges”
(page 6235). Moreover, the FDA Proposed Rule claims that intro-
duction of UVA I/UV Ratio will eliminate higher SPF value prod-
ucts which may provide poorer broad-spectrum protection than a
product labeled as broad spectrum with a lower SPF value.
The FDA defines how ratio calculations shall be performed.
The respective numbers used to calculate UVA I/UV ratio are
represented by the Area Under the Curve (AUC) per unit wave-
length. Similar logic follows ratio calculations in Boots Star rating
system used in the UK. To illustrate this process, and to verify the
FDA statement claiming that Product 2 passes, whereas Product
1 fails the new requirement, charts depicted on page 6235 of
the proposed rule were used for this demonstration. To define
numerical values of AUC for UVA I and UV spectral ranges, re-
spective areas were cut out from the chart and weighed on an
analytical balance. Results of the measurements were further di-
vided by the total number of wavelengths providing AUC/nm as
shown below:
Does this mean that passing the “FDA Proposed Rule”
guarantees passing in-vitro European requirements? As in the
Boots Star Rating System, the FDA does not require biologically
weighted spectrum to determine its ratio. Some of the EU meth-
ods, like Colipa and ISO 24443, calculate ratios using biologi-
cally weighted protection factors expressed by SPF and UV-PF
numbers. Moreover, these ratios are calculated from in vivo (SPF)
April 2019
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and in-vitro (UVA-PF) data. When comparing none-biologically
weighted ratios, we are only left with one option: Boots and the
proposed FDA. The FDA ratio defines relationship between UVA
I (340-400nm) and UV (290-400nm) spectra, whereas Boots ad-
dress the relationship between UVA (320-400nm) and UVB (290-
320nm). The fact that the FDA and Boots use different spectral
ranges to calculate respective ratios may result in products pass-
ing one method and failing the other.
Since ISO (former Colipa) seems to be accepted as the “in-
ternational guideline,” we have attempted to compare the FDA
Proposed Rule Ratio calculations against ISO 24443. Among nine
formulas tested, five passed the FDA Proposed Ratio and failed
ISO 24443. See two examples below:
Example A
Example B
The above graphs show that the FDA “Broad Spectrum” claim
does not necessarily pass EU requirements. In the above exam-
ples, it failed ISO but passed FDA. Even though the Proposed
FDA protocol is an improvement over the existing Critical wave-
length test, it still does not guarantee conformity with interna-
tional guidelines. To conclude, there are significant differences
between all the in-vitro methods.
Finally, if the only two ingredients that formulators are per-
mitted to use are zinc oxide and titanium dioxide, serious chal-
lenges are posed for producing an SPF product over 50. Also,
passing these new broad spectrum claims of UVA I/UV will be
extremely difficult for titanium dioxide-only formulations.
The other remaining issues that our sunscreen formulators
need to abide by are spray products and sunscreen-insect repel-
lent combination products.
Sprays are one of the most popular methods for delivering
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SUNSCREEN REGULATIONS IN THE US
sunscreens on the market today. Unfortunately, there are serious
challenges for formulating spray sunscreen products. Assuming
the safety data required by the FDA (flammability risk and re-
spiratory harm from inhalation) for spray products are passed, it
will be challenging, if not impossible, to produce aesthetically-
pleasing spray formulations using only ZnO and TiO2 filters.
These ingredients clog spray can valves and hence have not
been used to date to market aerosol propelled or bag-on-valve
spray sunscreen formulations. The cost of formulating inexpen-
sive beach products and mass-produced products is simply not
possible with the current inorganic particulate filters that are far
too expensive; compare the price of octyl salicylate to zinc oxide
and you will see it is many times more expensive. Of course,
some of the 12 currently Category III filters may need to be re-
approved for use, especially the only available UVA absorber,
the photo-unstable avobenzone that is propped-up with UV
absorbing quenchers. Otherwise, no one will have a chance
of achieving broad spectrum high SPF aerosol propelled spray
products again.
The new FDA proposal has recommended that combination
products containing insect repellants and sunscreens be classi-
fied as Category III non-GRASE. The justification has been that
the FDA and EPA regulations have different requirements espe-
cially as they relate to labeling. The emphasis, however, has been
on the use of EPA-approved insect repellents such as DEET and
IR 3535. Studies were presented that DEET may increase the skin
permeability of UV filters. Also, the recommended instructions to
reapply sunscreen after every two-hour of sun exposure subjects
the consumer to excessive amounts of the toxic insect repellent.
Therefore, one may ask, are the currently EPA-exempt natural
insect repellants (essential oils and other natural ingredients) al-
lowed in combination with sunscreens?
The FDA continues to skirt the issue of defining natural sun-
screens. The industry has created numerous products with nat-
ural claims by using zinc oxide and titanium dioxide inorganic
filters only. These filters are not even considered as chemicals by
the consumer relegating that definition to the other UV absorb-
ers only! The FDA, however, addresses the fact that inorganic
particulates, especially titanium dioxide, are ingredients that are
loaded with chemicals used for coating, emulsifying and solubi-
lizing those inorganic particulates to reduce their reactivity and
increase their usefulness (see p.6218). The FDA also ignores the
fact that inorganic particulates have a dual function of both re-
pelling and absorbing (through their inner d-orbitals) the sun’s
radiation. This conflicting data reported by the FDA does not help
in the least bit to define natural sunscreens on the market today.
The FDA acknowledges the photo-instability of the UVA
filter avobenzone. Astonishingly it recommends the use of UV
absorbers for the photo-stabilization of avobenzone regardless
whether these ingredients are approved Category I filters or not!
I surmise the FDA, in refusing to approve the photostable UVA
European TEA filters, is turning a blind eye to the practice of
happi • 9
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 SUNSCREEN REGULATIONS IN THE US

photo-stabilizing the only remaining, possibly to be approved,
photo-unstable UVA filter, avobenzone.
Nanotechnology
Nanotechnology is used to explore, or manipulate materi-
als measured in nanometers (nm) (billionths of a meter) and
has applications in a wide range of products, including OTC
sunscreens. According to the FDA, materials at 1 to 100nm di-
mensions “can have different chemical, or physical or biological
effects compared to large-scale counterparts, making possible
a variety of functional effects, and also potentially affecting
the safety, effectiveness, or regulatory status of FDA-regulated
products” (See p. 6215). Despite these preceding far-reaching
statements on different properties of varying nano-sized ingre-
dients, all grades of zinc oxide or titanium dioxide regardless
of their particle size are treated equally by their Category I sta-
tus. The FDA is not proposing to categorically classify products
manufactured using nanotechnology (or containing nanomate-
rials) as GRASE or not GRASE solely based on this characteris-
tic. I guess, stay tuned!
without saying that the pending TEA ingredients, or filters re-
sulting from the easing of the approval pathway for new, more
effective UVB and UVA filters that are less permeable to the
skin and offer more stable and safer broad-spectrum protec-
tion, may today be the only hope for formulating effective sun-
screens in the US. •
References:
1. FDA, Guidance for Industry,“Enforcement Policy—OTC Sunscreen Drug
Products Marketed Without an Approved Application,” May 2018 (available
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM259001), accessed June 7, 2018.
2. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sun
screen-drug-products-for-over-the-counter-human-use. 21 CFR Parts 201,
310, 347 and 352.
3. Federal Register/Vol.84, No.38, February 26, 2019 Reference 176 on page 6262.
4. Federal Register/Vol.84, No.38, February 26, 2019 Reference 177 on page 6262.
5. Federal Register/Vol.84, No.38, February 26, 2019 Reference 178 on page 6262.
6. Federal Register/Vol.84, No.38, February 26, 2019 Reference 179 on page 6262

Closing Thoughts About the Author

In conclusion, the FDA’s goal to finalizing the Sunscreen
Monograph by Nov. 26, 2019 is totally unrealistic despite my
repeated calls in the past to issue a Final Monograph. I cannot
perceive a condition or a company coming forward to sup-
ply the necessary safety data required by the FDA to reclas-
sify a Category III UV filter as GRASE. Perhaps avobenzone
from this list of 12 “may be” the only such ingredient. It goes
Nadim A. Shaath, PhD, is the president of Alpha Research &
Development Ltd., in White Plains, NY. He has over 30 years of
experience as chairman of the chemistry department at SUNY-
Purchase and as the CEO of Kato Worldwide. His book, “Healing
Civilizations: The Search for Therapeutic Essential Oils and
Nutrients,” was published by Cameron Books, Pasadena, CA. He
can be reached at alpharnd@aol.com

Follow the Leaders…

…in the July & August of Happi
Happi’s The Top 50 & The International Top 30, published in July & August,
provide a look at the leading companies in the global Household & Personal
Products Industry. To learn more about Procter & Gamble, Unilever, L’Oréal,
Estée Lauder and other multibillion dollar, multinationals perform,
be sure to read the July & August editions of Happi.

10 • happi happi.com April 2019

eBook_Final_0419.indd 10 4/10/19 1:42 PM

 Skin Damage
Caused by UV
Burn, baby, burn.
Ultraviolet radiation
from the sun is a hot topic
in the skin care sector.

An in-depth look at how ultraviolet radiation affects skin health and how it can be repaired.

Paolo Giacomoni • Insight Analysis Consulting

W
HEN THE SKIN is exposed to excess ultraviolet (UV) ra-
diation from the sun or from another light source, it
turns red and the consumer suffers the pain of sun-
burn. This redness is the so-called solar erythema (reddening due
to the sun), a clinical manifestation of the inflammatory response
to damage caused by UV. The trigger of this inflammatory re-
sponse is DNA damage. Other clinical signs of sun damage can
be observed after exposure to solar radiation.
In the days following the exposure, the skin’s immune system
is impaired, and the skin does not react to antigens for several days.
This immune damage manifests itself in the loss of the so-called
Contact Hypersensitivity and of the Delayed-Type Hypersensitivity,
which last a few days after exposure. Interestingly enough, the UV
dose necessary to inhibit the immune response is smaller than the
dose needed to elicit an erythema.
The skin also acquires a golden brown color, which is called
facultative pigmentation, and is known in layman’s terms as a
tan; but this is only true for a portion of the population. Albinos,
those people unable to produce melanin, do not tan. Other peo-
ple, albeit non-albino, get such a weak tan that, when they are
asked about the behavior of their skin under solar radiation, they
say that they always burn and never tan. Among Caucasians, one
also finds people who always tan without burning and acquire
colors that range from dark brown to golden with all the inter-
mediate shades. Many Mongolian Asians, when exposed to UV
radiation, acquire a dark lemon-yellow color, which they often
find unwelcome. Africans and African-Americans can burn when
exposed to UV, but in this case, it is more difficult to evaluate
clinically; i.e., by visual inspection, the onset of facultative pig-
mentation or sunburn.
melanocytes in the epidermis exposed to UV. The melanocytes are
neural cells that reside in the epidermis and some scholars say that
a tan is a signal that damage has occurred. Melanin is transferred
to keratinocytes where it agglutinates around the nucleus of the
keratinocytes and forms so-called supra-nuclear structures.
For a long time, it was believed by scientists and lay people,
that a tan was a protective reaction of the skin. Of course, we
now know that this is not the case. There are many scientific pa-
pers showing that the protection offered by a tan is minimal. In
a paper from the Karolinska Institutet in Sweden,1 the authors
report data indicating that there is no real difference in the gen-
eration of photodamage in tanned or non-tanned skin. Another
example can be found in a paper2 by Japanese researchers which
clearly demonstrates that, under UV irradiation equivalent to
several hours of solar exposure in Long Island (or Barcelona or
Naples) in July, the number of photoproducts induced under a
tan is only four times less than under a non-tanned skin.
When exposure to solar radiation is prolonged over a lifetime,
other manifestations occur, such as lentigo senilis (age spots) and
elastosis, not to say of seborrheic keratosis and skin cancer. Yes,
Sun damage is
more than skin deep.

What’s Happening
A tan is the consequence of the production of melanin by the

April 2019 happi.com happi • 11

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eBook_Final_0419.indd 12 4/10/19 1:42 PM
 we protect
Each personal care formulation poses unique challenges for preservation.
At schülke, we have options to protect each one from contamination.
Consumers want products that are effective, but are
also safe and sustainable. To protect these products,
schülke provides their euxyl® perservatives and sensiva®
multifunctional cosmetic additives that protect your
leave-on, wet-wipe and sensitive skin applications from
microbiological contamination. sensidin® DO kills
odor-causing bacteria on skin, without adversely
affecting the body’s microbiome.
sensiva® multifunctional additives promote the
antimicrobial stability of your products, boost the
efficacy of preservatives, improve skin-feel of all of
your formulations, and are extremely effective against
odor-causing germs.
schülke inc. | Fairfield, NJ | USA |
Tel. 1-973-770-7300 | Toll-free 1-888-267-4220 | saius@schuelke.com
eBook_Final_0419.indd 13
euxyl® products offer optimum preservation against
bacteria, yeast and mold to fit your every need, in an
easy-to-use, energy-saving liquid form.
sensidin® DO provides excellent efficacy in
deodorants at very low use concentrations.
At schülke, we protect your formulations,
because at schülke we protect life.
Find out how schülke
can help protect you at
schulke-us.com/ebook419
Schülke & Mayr GmbH | 22840 Norderstedt | Germany |
Tel. +49 40 521 00- 0 | www.schuelke.com | info@schuelke.com
4/10/19 1:42 PM
 UV DAMAGE
the signs of aging and the rate of their appearance are linked to
one’s lifestyle!
Exposure to too much sunlight during one’s youth is revealed
later in life by the onset of age spots. This is particularly true in
Mongolian Asians but it is also often observed in Caucasians.
Age spots typically appear after the age of 50 on those skin areas
which have been frequently and intensely exposed to sunlight.
The histological analysis; i.e., the scrutiny of biopsies, reveals
that where there is an age spot, the epidermis is thicker and pen-
etrates deeper into the dermis, and traces of inflammation are
perceptible. This epidermal thickness would provoke a darker ap-
pearance even if the cells contained the same amount of melanin
per cell as the surrounding cells. It happens that within an age
spot, cells contain more melanin per cell3,4 and this accumulation
of melanin could be the consequence of the impairment of the
biochemical functions committed to the elimination of melanin.4
Another consequence of prolonged exposure to sunlight is
elastosis. A permanent inflammatory status of the skin, elicited
by continuous exposure to UV, makes it so that macrophages are
constantly recruited from the blood vessels to remove damaged
cells from the cutaneous tissue. In doing so they have to cross
the dermis and digest the elastic fibers that make it resilient. In
the long run, the elastic fibers grow disorganized and elastin is
deposited, with the final consequence of elastosis and a total loss
of skin elasticity and resilience.5
Know Your UVA & UVB
From what precedes, we can conclude that solar radiation is clini-
cally damaging to the skin. The harmful component of solar ra-
diation is the ultraviolet portion and perhaps, part of the visible.
Ultraviolet from the sun is composed of UVB and UVA. It has
been said that UVB “burns” and that UVA “ages.” In reality, both
UVA and UVB provoke DNA damage that triggers an inflamma-
tory reaction. The effect of inflammation is to multiply and accu-
mulate damage and accelerate aging. In the course of repair, the
removal of damaged nucleotides (the building blocks of DNA) is
followed by the restoration of the pristine sequence of the DNA.
Unfortunately, this does not always happen and there is a min-
ute yet finite chance that an error is made in the course of DNA
repair. This error is called a mutation. Accumulation of mutations
can lead to skin cancer.
Per photon, UVA provokes less DNA damage and mutations
than UVB, but in solar radiation there is 20 to 50 times more UVA
than UVB so that the damaging, mutagenic and carcinogenic
power of UVB and UVA in solar radiation is similar.
It has been said that UVB is more energetic than UVA; that
is true. It has also been said that UVA penetrates the skin more
deeply than UVB; that is also true. This seems contradictory. In re-
ality, energy has nothing to do with penetration: UVB is strongly
absorbed by the DNA and the RNA of the cells of the epidermis,
and therefore it does not penetrate in the dermis. UVA and visible
light are poorly absorbed by DNA and RNA, if at all, and they can
14 • happi happi.com April 2019
eBook_Final_0419.indd 14
There is no such thing as a healthy tan.
cross the epidermis and penetrate more deeply in the skin.
UVA and visible light can be absorbed by endogenous photo-
sensitizers. Photosensitizers are molecules able to transfer the
absorbed energy to oxygen and transform it in the extremely re-
active singlet oxygen with dire consequences for molecules that
can be oxidized, such as the lipids in the stratum corneum, the
lipids and proteins composing cell membranes, as well as the
DNA itself.
Protect Yourself
To avoid the damage, it is necessary to protect the skin against
solar radiation, and sun filters and antioxidants are manufactured
and formulated for this reason. Sunscreens against UVB are la-
beled with a protection index called Sun Protection Factor.
The Sun Protection Factor is calculated as:
UVB dose necessary to induce a minimal erythema with sunscreen
SPF =
UVB dose necessary to induce a minimal erythema without sunscreen
In other words, the SPF is a number indicating how much
LESS damage is made when wearing the sunscreen.
African-American skin, and Black skin in general, does
not provide adequate protection: it is the equivalent of an SPF
of 7-8. Shirts and T-shirts offer SPF which can be as low as 10.
Paradoxically, topical ointment can be better protectants than fab-
rics! With an SPF 30, one gets 30 times less damage than without,
and using an SPF 50, one gets 30 times less damage than without.
In order for sunscreens to offer the SPF or the UVA-
Protection factor written on the label, one must apply 2mg/cm2,
which is about one to one and a half ounce per human body.
The sunscreen does not last forever: sweating, swimming, rub-
bing against each other remove the sunscreen. When outdoors it
is a good practice to re-apply the sunscreen every two hours. The
4/10/19 1:42 PM

fact of applying a sunscreen after two hours, does not remove the
damage generated while one was exposed to solar radiation in
the previous two hours.
There is the belief that the higher the SPF, the better it is. It is
not always true. First of all, to double the SPF of a sunscreen one
has to formulate sunscreens with more than just twice the sun-
filter, sometimes up to three or four times or even more, and this
might mean adding more of a potential irritant to the skin.
For “broad spectrum” sunscreens, which protect against both
UVB and UVA, there is also an indication of the UVA protection
(UVA-P) by a number or by stars. Many UVA filters are unstable
because the absorption of UVA provokes the destruction of the
filter, exactly as the light from the flash of photographic cameras
of the tourists provokes the loss of the colors in paintings and
frescoes in Italian churches. The use of large concentrations of
UVA filters might generate an excess of degradation products
that can be irritating to the skin.
Repair Mechanisms
Repair is damage removal. The study of skin biochemistry tells
us that skin cells are able to perform a certain number of repair
actions. Damaged proteins are disassembled within the cell, in
specialized organelles called lysosomes, and new ones are syn-
thetized. Vitamin D has the capability to induce the production
of “chaperone” proteins (also called heat shock proteins or HSP)
that can accompany damaged proteins to the lysosomes.
Damaged DNA is repaired by complex DNA-repair systems
that remove the chemically modified nucleotides and restore the
pristine DNA sequence. Nucleotides can be modified by direct
absorption of a UV photon and give rise to different types of py-
rimidine dimers. They can also react with reactive oxygen species
such as singlet oxygen or the superoxide anion and end up form-
ing 8-oxo guanine and other oxidation products of pyridines.
DNA damage can also take the form of nicks in the sugar-phos-
phate backbone or of the opening of the deoxy-ribose moiety.
Many DNA repair pathways need the polymerization of a
molecule called nicotinamide adenine dinucleotide (NAD) that is
obtained from vitamin B3 and that is essential for the production
of energy. It can happen that, despite having its DNA repaired, a
cell dies because all of its NAD has been polymerized and energy
can longer be produced. This is very unfortunate because a dead
cell triggers the inflammatory response, thus accelerating the
process of skin aging. It has been shown on human skin in vivo
that the topical application of vitamin B3, in the nicotinamide
form, after exposure to UV, boosts DNA repair and energy pro-
duction, thus resulting in the restoration in the immune system
of the skin.
When it comes to macroscopic repair, the removal of visible
damage is more problematic. Some UV-induced macroscopic
damage such as wrinkles or elastosis are the result of structural
modifications and disorganization of the elastic fibers—none of
which can be removed just like that!
April 2019 happi.com happi • 15
eBook_Final_0419.indd 15
UV DAMAGE
Regardless of Fitzpatrick Type, everybody,
eventually, suffers from UV damage.
The repair of age spots is also complex, insofar as the num-
ber of genes involved in the control of pigmentation is greater
than one hundred6 which adds to the difficulty in understand-
ing the genesis of the age spots. Without this understanding it
is difficult to design a simple strategy to remove the age spots
and as of today we can only utilize ingredients able to inhibit
the enzymes involved in the synthesis of the melanins, hinder
the transfer of the melanosomes from the dendrites to the ke-
ratinocytes, and to accelerate the removal or the digestion of
the melanins.
For a more in depth approach to UV damage, protection and
repair, see references 7 and 8. •
References
1. Bykov et al (2001) Dermatology 202 : 22-26
2. Kobayashi et al (1998) J. Invest. Dermatol. 110 : 806-81
3. Hodgson C (1963) Arch. Dermatol.Siphilol. 87 : 197-207
4. Braun-Falco O, Schoefinius HH (1971) Der Hautartz 22 : 277-283
5. Giacomoni PU, Rein G. (2004) Micron. 35:179–184.
6. Yamaguchi Y, Hearing VJ (2009) Biofactors. 35:193-199.
7. Sun Protection in Man (Paolo U. Giacomoni, editor) Elsevier,
Amsterdam, 2001
8. Biophysical and Physiological effects of solar radiation on human
skin (Paolo U. Giacomoni, editor). The Royal Society of Chemistry,
Cambridge (2007).
About the Author
Paolo Giacomoni, PhD, acts as an independent consultant to the
skin care industry. He served as executive director of research
at Estée Lauder and was head of the department of biology at
L’Oréal. He has built a record of achievements through re-
search on DNA damage and metabolic impairment induced by
UV radiation as well as on the positive effects of vitamins and
antioxidants. He has authored more than 100 peer-reviewed
publications and has more than 20 patents. He can be reached at
516-769-6904; email: paologiac@gmail.com
4/10/19 1:43 PM
 The Ultimate
Protection for
Sun Protection
S
UNSCREENS are more effective than ever, but
today’s ultra-high SPF systems can be a
challenge to preserve. This is particularly true
when using modern, non-traditional preservation
methods. The preservation experts at schülke have
found that sensiva® PA 40 is the perfect solution
for these difficult-to-preserve systems. A blend of
natural, nature-identical and gentle synthetic ma-
terials, sensiva® PA 40 has proven effective in for-
mulations where other similar preservative blends
have failed.
In their continuing effort to provide customers
with the best formulation guidance, schülke has
researched why some formulations are harder to
preserve than others. This research first led schül-
ke to investigate the effects of natural oils in emul-
sions. The findings from this investigation have
paved the way to further studies in the preserva-
tion of other hard-to-preserve formulations, such
as sunscreens.
Although different in many ways, products
containing natural oils and high SPF sunscreens
pose similar problems with regard to preservation
—both often contain high levels of polar oils and
esters. Traditional preservatives, like formaldehyde-
donors and isothiazolinones, are extremely water-
soluble and remain in the water phase of emulsions,
where microorganisms exist. Because of this, tradi-
tional preservatives remain effective, even in high
oil-phase systems. However, many newer, alterna-
tive preservation methods (i.e., containing caprylyl
glycol, phenethyl alcohol, ethylhexylglycerin) have
limited water solubility. Therefore, the partition co-
efficient between oil and water phase of preserva-
tives/antimicrobial boosters plays an important role
regarding their efficacy in emulsions. For this rea-
son, these newer systems may be less effective in the
presence of high levels of polar oils.
Sunscreen formulas based on organic sun fil-
ters become increasingly difficult to preserve as

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 THE ULTIMATE PROTECTION FOR SUN PROTECTION

the SPF increases. This can be attributed to the in-

creasing level of polar oil phase. schülke tested an
SPF of 30 sunscreen based completely on organic
sun filters to determine optimum preservation
(Figure 1). sensiva® PA 40 (a blend of natural, na-
ture-identical and gentle synthetic materials) was
tested against euxyl® PE 9010 (phenoxyethanol +
ethylhexylglycerin), euxyl® K 900 (benzyl alcohol
+ ethylhexylglycerin) and euxyl K 940 (phenoxy-
ethanol + benzyl alcohol + ethylhexylglycerin) in
a standard 28-day, single inoculation germ-count
reduction test. This testing showed sensiva® PA
40 used at 1.5% was the only variant that reduced
the germ load of all organisms effectively for the
full duration of the test (Figure 2).
Sunscreens based on inorganic sun filters
have grown increasingly popular. They also pose
unique challenges in preservation. Like other
products with high levels of particulate (i.e. liquid
foundation make-up), the presence of particulate
increases the susceptibility of the product to mold
contamination. Mold prefers to grow on surfaces
and the titanium dioxide in these products offer an
ample amount of surface area to support growth.
In contrast, zinc oxide is used in diaper rash treat-
ments for its antimicrobial properties. The inclu-
sion of this material as a sun filter should boost
the preservation of the formula.
In testing a High SPF Inorganic Sunscreen
(Figure 3), schülke focused on two non-traditional
preservation methods. euxyl® PE 9010 was tested
versus sensiva® PA 40 in a 6-inoculation, 6 week
preservative efficacy test (Figure 4). While both
systems were able to effectively preserve the sun-
screen with the addition of a chelating agent, sensiva® PA 40 was services help you to protect people and materials against infection
effective at lower concentration. Used without a booster at a use and contamination.
level of 1.0%, euxyl® PE 9010 could not adequately preserve the Our company philosophy is based on a total quality concept that
sunscreen. sensiva® PA 40 is not limited by the same regulatory considers the quality of our products in the sense of effective product
restrictions as products containing phenoxyethanol. It can be formulas, as well as workplace safety, environmental management,
used at 1.5% to effectively preserve this system without the need and leadership and cooperation.
for any additional boosting. Our euxyl® brand provides numerous preservative blends for the
Modern, high-SPF sunscreens are difficult to preserve. The cosmetic industry. These optimized combinations of active substances
accompanying trend toward softer, non-traditional preservation offer broad spectrum efficacy, keeping cosmetic products free of micro-
methods can add to the complexity of formulating these systems. bial growth.
The preservation experts at schülke understand the ever-chang- Our sensiva® brand includes versatile, multifunctional skin care
ing needs of the personal care industry. additives for personal care products. Their unique properties make
Let the experts at schülke help you preserve and protect your them suitable for use in a wide range of cosmetic applications — in-
most demanding products. cluding creams, lotions and deodorants. schülke‘s specialist expertise
helps take the guesswork out of preservation.
About schülke
Since 1889, Schülke & Mayr GmbH has been one of the world‘s lead-
ing names in preservation and industrial hygiene. Our products and Visit us online at schulke-us.com to find out how!

April 2019 happi.com happi • 17

eBook_Final_0419.indd 17 4/10/19 1:43 PM


WHAT LIES BENEATH
With new laws impacting what sunscreen formulations can be sold at retail in places
like Hawaii and Key West, FL, “reef safe” products are gaining more attention in the US
marketplace. Here’s a look some of the indie brands that formulate sun care products
designed to protect skin and sensitive eco-systems, too.
By Happi Staff
A
S ANY SKIN CARE expert will tell
you, sunscreen is about three
things: protection, protection
and protection. Over the years, formula-
tors have placed extra emphasis on mak-
ing lotions that are easier to apply and
have greater water-resistance. But new
laws that have been recently passed in
Hawaii and Florida are shifting the focus
away from how the sunscreen feels and
performs on the skin to what happens
when it comes off and enters the water.
Both Hawaii and Key West, FL re-
cently passed new laws that will end
the retail availability of sunscreens that
contain oxybenzone and octinoxate, a
This SPF 30 sport sunscreen comes
from Stream2Sea, a member of the
Safe Sunscreen Council.
18
eBook_Final_0419.indd 18
A new law passed in Hawaii is designed
to protect areas like Diamond Head in Waikiki.
pair of ingredients that are said to dam-
age sensitive ecosystems by contrib-
uting to coral bleaching. (Hawaii and
Key West aren’t alone; the country of
Palau has also issued a ban and popu-
lar vacation locations in Mexico request
visitors use biodegradable formulas.)
These changes are welcomed by envi-
ronmental advocates and companies
that already have sunscreens that are
formulated with natural mineral ingre-
dients, namely titanium oxide or zinc
oxide, and therefore are already consid-
ered “reef safe.”
While these US mandates are new,
the “reef-safe” sunscreen market isn’t. In
W.S. Badger’s new SPF
fact, the category was created by a bevy of 30 Clear Zinc Lotion is
indie brands that contends they have al- reef safe, just like the rest
ways emphasized protecting skin, humans of its sun care products.
and the ecosystem.
4/10/19 1:43 PM
 REEF-SAFE SUNCARE

Active Brands
One of them, W.S. Badger Co., was quick to applaud Hawaii’s
new law. This family-owned brand offers 16 sun care SKUs,
all of which are compliant with the legislation. The brand’s
newest options include clear zinc sunscreens. The new SKUs
include two unscented options—SPF 30 Clear Zinc Lotion for-
mulated with 15% zinc oxide, and SPF 15 Clear Zinc Lip Balm
(which has a 97% organic base)—and an SPF 40 Kids Clear
Zinc Cream, which comes in a tangerine and vanilla scent
reminiscent of a creamsicle. The latter, which contains 98%
organic base ingredients, was named a 2019 Natural Products
Expo West NEXTY Award winner in the Best New Natural
Kid’s Product Category.
Badger’s expansion of its sunscreen stable builds upon a de-
cade-plus long history of formulation as the firm launched its first
broad spectrum sunscreen in 2005. And, the Gilsum, NH-based
company is also a member of the Safe Sunscreen Council, a co-
alition of brands that works to raise awareness within the skin
care industry and consumers to support the development and
adoption of safer ingredients for people and planet. In addition to
Badger, current members of the Safe Sunscreen Council include:

• All Good (https://allgoodproducts.com)

• Babo Botanicals (https://www.babobotanicals.com)
• Kokua Sun Care (https://www.kokuasuncare.com(
• Mama Kuleana (https://www.mamakuleana.com)
• Manda (https://mandanaturals.com)
• Raw Elements (see Indie Inc. in our March issue; https://
www.rawelementsusa.com)
• Raw Love (https://rawlovesunscreen.com)
• Sea & Summit (https://seaandsummitsunscreen.com)
• Stream2Sea (https://stream2sea.com)
• Suntegrity (https://www.suntegrityskincare.com)
• ThinkSport (https://gothinksport.com)

“When it comes to new formulations, our philosophy is to

make the most enjoyable, effective and safe products on the
market,” said Caroline Duell, founder and CEO of fellow Safe
Sunscreen Council member All Good, when her company un-
veiled two new sun care products at Natural Products Expo West.
Morro Bay, CA-based All Good’s newest sunscreens include a
pair of tinted products: All Good Tinted Sunscreen Butter SPF 50,
which is formulated with 25% non-nanoparticle zinc oxide, iron
oxides, organic coconut and jojoba oils, vitamin E and beeswax;
and Tinted Sunscreen Lotion SPF 30, which contains an organic All Good recently added this reef friendly tinted SPF 30 sunscreen.
blend of calendula, buriti oil, green tea leaf extract and 18% non-
nanoparticle zinc oxide and iron oxides. Both reef-safe formulas
provide UVA/UVB protection and are water resistant and GMO-
and gluten free. “Wearing sunscreen daily can reduce skin aging by 24%. That
Another Council member, ThinkSport, recently unveiled an is enough to even get men to wear sunscreen daily. This formula
updated tube design for its Every Day Face product. The sunscreen also works great as a base layer before applying makeup,” he said
has the ability to seamlessly blend with all skin colors without about the formula, which contains 20% zinc oxide and is en-
any whitening effect, according to Kevin Brodwick, founder and riched with vitamins and moisturizers.
“chief thinker” at the company, which is based in Austin, TX. In addition to being a member of the Safe Sunscreen Council,

19

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 REEF-SAFE SUNCARE
ThinkSport products were
the first to pass Whole Foods’
Premium Care requirements
and have been Environmental
Working Group rated“1”since
launch, according to the com-
pany, which also sells deodor-
ant, lip balm and other types
of healthier lifestyle consumer
products—think water bottles
and yoga mats built with
healthier materials.
Boulder, CO-based brand
Goddess Garden touts reef-
safe mineral sunscreens, too,
and has recently added new
SPF 50 formulations in its
Sport, Daily, Kids and Baby
lines. The firm also added
new lotions and sticks that
Goddess Garden offers this reef-safe
SPF 50 formulation for baby.
20
eBook_Final_0419.indd 20
use a premium, ultra-sheer zinc. Goddess Garden’s best-selling
Everyday SPF 30 line is also still avail-
able, but it has been renamed “Daily” to
help reinforce the critical practice of us-
ing protective products every single day.
The new product developments at
Goddess Garden are always focused on
making great formulations that are safe
for the earth and end-users alike.
“My daughter’s sensitive skin in-
spired my company, so we’ve always
been about making safer sunscreen
for our families,” explained Nova
Covington, who is CEO of the Certified
B Corporation.“After learning sunscreen
chemicals kill coral, we redoubled our
efforts to spread the word about reef-
safe mineral sunscreens.”
Will coral-killing creams and lotions
remain hot topics for the sun care indus- ThinkSport Every Day
try? Probably; and that means yet an- Face product has been
other controversial topic swirling about given a packaging facelift.
this multibillion dollar industry. •
4/10/19 1:43 PM
 Summer 2019
Here’s a look at some of the newest sun care offerings that
are reaching store shelves now, well ahead of beach season.

By Happi Staff

Baby Bum’s SPF 50 Sunscreen Stick and Lotion

• Ideal for both moms and kids, Baby Bum’s SPF 50 Sunscreen Stick and Lotion are
plant-based formulas that will protect the most sensitive skin from harsh UVA/UVB rays.
Baby Bum’s Sunscreen Stick creates a unique and fast process to putting on sunscreen!
Perfect for on the go, the product has a smooth glide that rubs easily and can be applied
to all body parts. Featured ingredients include 100% mineral based protection including
coconut oil, shea and cocoa butter and restorative oils.
The lotion is made with a lightweight, non-greasy formula that is easy to apply.
Featured ingredients include 100% mineral based protection including coconut oil, shea
and cocoa butter and restorative oils.
More info: www.babybum.com

Coola - Full Spectrum

360 Mineral Sun L’Occitane Immortelle/Precious
Silk Crème Organic Divine Light Cream SPF 20
Sunscreen SPF 30 • L’Occitane is launching new luxuri-
• This multi-tasking mod- ous SPF creams. L’Occitane Immortelle
ern masterpiece does it all. Divine Light Cream SPF 20 ($110) and
Coola — Full Spectrum 360 Immortelle Precious Light Cream SPF
Mineral Sun Silk Crème 20 ($64) feature organic and sustainable
Organic Sunscreen SPF 30’s Immortelle, UV protection, and mois-
oil-free, airy-light formula ture for a healthy glow, acording to the
gently glides on to form a company.
transparent veil, ideal for More info: www.loccitane.com
everyday use. Non-nano
zinc oxide provides broad
spectrum UVA/UVB protec-
tion while the plant-derived
full spectrum 360° complex
helps mitigate the effects of
today’s modern-world skin-
aggressors – HEV light, IR,
and pollution.
More info:www.coola.com

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 NEW PRODUCTS

Dermalogica Prisma Protect SPF30

• The Dermalogica Prisma Protect SPF30 ($65) is a master multitasker – it not
only defends against UV light, but actually uses the light to skin’s benefit, while also
moisturizing skin and protecting against damaging pollution & free-radicals, accord-
ing to the company. Prisma Protect SPF30 works in tandem with skin’s natural day-
time defense mode to provide protection, boost skin’s natural luminosity, and deliver
lasting hydration. Light-activated intelligent drone technology converts visible light
to help boost skin’s natural luminosity. Plant-derived advanced moisture magnets
connect with skin’s surface layers — providing all-day hydration for visibly smooth
skin. Matcha tea (Camellia sinensis) from Japan provides 100 times more polyphenols
than traditional green tea along with exceptional antioxidant protection, helping to
defend skin against pollution. A bio-ferment from sage helps to brighten and even
skin tone.
More info: www.dermalogica.com

Contains Only Titanium and Zinc

• Cōtz, which stands for Contains Only Titanium and Zinc, recently expanded its collection of mineral sunscreens and
tweaked a customer favorite. New options include Cōtz Face Moisture SPF 35, a lightweight, hydrating facial mineral sunscreen that
incorporates zinc oxide and ceramides to help reinforce the skin’s natural lipid barrier. It is formulated with 16% zinc oxide and is
also free from gluten, oils, preservatives, parabens, phthalates and fragrance.
More info: cotzskincare.com

Volition Prismatic Matrix Total

Luminizing Shield SPF 50 Results Keep Me
• This new product from Vivid Velvetizer
Volition is said to offer every- • Matrix Total Results
thing you want from a luxury Keep Me Vivid Velvetizer
skin care product and nothing ($18) is a unique oil-to-
you’d expect from a sunscreen— crème leave-in styling
nourishing, hydrating, indulgent. balm with smoothing
This breathable, weightless fluid capabilities and UV plus
effortlessly protects your skin heat protection.
from the sun while leaving a More info: www.matrix.
soft, luminous glow. Titanium, com/total-results/products/
zinc oxide and octinoxate offer keep-me-vivid/keep-me-
sun protection while licorice, vivid-color-velvetizer
kiwi fruit water and ku shen
root extracts work as anti-aging
components.
More info: VolitionBeauty.com

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 NEW PRODUCTS

Women and Children First!

• Earth Mama Organics rolled out a range of mineral sunscreen
lotions for women, kids and babies. Certified to the NSF/ANSI 305
Organic Standard, the formulations contain non-nano zinc and
organic ingredients that the company says are “purposely sourced
with great consideration to either boost the sunscreen’s SPF value, its
ability to moisturize or its gentle, safe effect on uber-sensitive skin.”
More info: https://earthmamaorganics.com

Be an Ultra Sport!
• Edgewell also upgraded the Banana
Boat Sport line with new Ultra Sport,
lotion and spray formats that offer high-
performance but lightweight and breath-
able formulas. The SKUs range from SPF
15 to SPF 100.
More info: www.bananaboat.com
A New Kind of Blue
• Blue Lizard mineral and mineral-based sunscreens just
went through a redesign which includes improved formula-
tions to deliver safe, effective products that comply with new
reef-safe sunscreen legislation.
More info: www.bluelizard.net

Into the Mist

• Hawaiian Tropic
Antioxidant Plus
Refresh Sunscreen
Mist is described
as oil-free, ultra- A Simple Idea
weightless and • Coppertone’s new Pure &
moisturizing, and, Simple is designed for the whole
according to the family. It is formulated with 100%
brand, perfect for zinc oxide and 100% natural
one’s everyday botanicals (a blend of tea leaf, sea
beauty routine. The kelp and lotus extracts).
scent is infused More info: www.coppertone.com
with mango,
guava, papaya and
passionfruit.
More info: www.
hawaiiantropic.com

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 Head Toward
the Light
The Florida Chapter of the Society of Cosmetic
Chemists’ biannual Sunscreen Symposium is set
for September 12-14, 2019 in Orlando.

• The Florida Chapter of the Society of Cosmetic Chemists industry including a board-certified dermatologist with more
presents its 2019 Sunscreen Symposium “Integrating Beauty than 40 years of experience, poster exhibits & presentations, and
through Suncare, Anti-Aging and Skin Cancer Protection.” tabletop exhibits from companies offering the latest materials &
services in the cosmetic industry.

Here’s the schedule:

Thursday, September 12
7:30am: Registration Open for CEP attendees
8:00am - 1pm: CEP Course – New Sun Care Formulation
Concepts (Must be registered for the Symposium)
9:00am - 1pm: Golf Outing (requires a sign up fee)
5:00 - 8:00pm: Cocktail Reception. Posters and Exhibits
Open. Registration Open

Once again, Walt Disney World is the site for the Sunscreen Symposium
Friday, September 13
8:00am - 3:30pm: Technical Presentations, Posters and
Historically this event draws hundreds of cosmetic industry Exhibits Open
professionals who travel from around the world to learn more 7:00pm: Caribbean Carnival Themed Symposium Party
about the latest scientific developments on a global scale, hear
updates on current regulations, and learn more about various sci- Saturday, September 14
entific subjects. 9:00am - 3:30pm: Technical Presentations, Posters and
The event will be held at Disney’s Yacht Club in Lake Buena Exhibits Open
Vista Florida, September 12-14, 2019. This year’s Symposium
features 15 podium presentations from experts in the sun care Visit www.flscc.org for more information and to register.

Palm trees and UV protection are on tap. Be sure to register for the golf outing.

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 we protect
Every product poses unique challenges for preservation.
With sensiva® SC 50, schülke protects your formulations.
Consumers want cosmetics products that are
effective, but many creams and lotions present unique
microbiological challenges. To meet these needs,
schülke provides sensiva® SC 50 – a multifunctional
preservative booster that gives you peerless protection
for your formulations.
sensiva® SC 50 is an incredibly versatile multifunctional
additive, as well as a very effective deodorant active.
In addition, it also improves the skin feel of cosmetic
formulations when used as an emollient.
schülke inc. | Fairfield, NJ | USA |
Tel. 1-973-770-7300 | Toll-free 1-888-267-4220 | saius@schuelke.com
eBook_Final_0419.indd 25
sensiva® SC 50 reliably inhibits the growth and
multiplication of odor-causing bacteria, while not
adversely affecting the microbiome. sensiva® SC 50
can boost the efficacy of traditional preservatives
and act as an antimicrobial stabilizer in combination
with other cosmetic ingredients.
At schülke, we protect your formulations,
because at schülke we protect life.
Schülke & Mayr GmbH | 22840 Norderstedt | Germany |
Tel. +49 40 521 00- 0 | www.schuelke.com | info@schuelke.com
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