COSMETIC - PRELIM
RAW MATERIALS
FDA defines a cosmetic as a product (excluding
pure soap) intended to be applied to the human
body for cleansing, beautifying, promoting
attractiveness, or altering the appearance.
Cosmetic Science
→ is a multidisciplinary applied science.
→ majors study the art, science and business of
cosmetics.
→ They learn to develop, formulate and produce
cosmetics and personal care products.
→ They also study regulations and how to assess
products’ safety, performance and quality.
→ As a specialist in Cosmetic Science &
Formulation Design, you will aid in developing,
formulating, manufacturing, testing, and
marketing cosmetics and personal care
products such as lipstick, eyeshadow,
shampoo, hair coloring and other products for
adults, children and babies.
→ Cosmetic Science & Formulation Design majors
are prepared for careers in:
• Research
• Skin, hair and nail therapy
• Product development and
formulation
• Production/manufacturing
• Quality control and quality
assurance
• Packaging
• Product stability testing
• Regulatory affairs
• Acute and chronic toxicity testing
• Consumer affairs
CHEMISTRY
→ Since all cosmetics are made up of chemicals
(yes even so-called “natural” cosmetics are
chemicals), the most important aspect of
cosmetic science is chemistry.
→ This is the study of chemicals and how they
interact with each other.
→ As a cosmetic scientist you need to first get to
know the cosmetic raw materials available and
what they do. You also need to learn how to
put the raw materials together into a safe and
effective formula.
→ The raw materials that are used in most
cosmetics around the world are listed in the
International Nomenclature of Cosmetic
Ingredients Dictionary. The latest edition of
the INCI Dictionary has over 22,000 entries so
it takes some time to learn about everything
you could include in your cosmetic
formulas. In reality, those thousands of
options can all be simplified and we’ve
described how there are really only
three types of cosmetic ingredients. These
include functional, aesthetic and claims.
• Functional ingredients are the ones that
provide the benefit of cosmetics. They include
cleansers (surfactants), conditioning agents,
colorants, fragrances, reactive ingredients,
film formers, and drug actives. Every cosmetic
you’ve ever used or made has at least one
functional ingredient.
• Aesthetic ingredients are those that help
make delivery of the functional ingredients
more acceptable. These are ingredients like
solvents, thickeners, preservatives, fragrances,
pH adjusters, plasticizers, fillers, appearance
modifiers, anti-oxidants, anti-irritants, and
delivery systems.
• Claims ingredients (sometimes called fairy
dust) are ingredients added to a formula at a
low level for the primary purpose of getting to
put the ingredient name on the label. This
includes ingredients like natural extracts,
vitamins, proteins, biotechnology, and fanciful
made-up ingredient names.
• Formulating
While knowing the raw materials is important, it is
equally important to know how to put the
ingredients together in a formulation. There are a
wide variety of formulation types including
solutions, emulsions, gels, sticks, aerosols,
powders and more.
Physics
Depending on the type of products you are making,
there are a number of topics in the field of physics
that are important. For color cosmetics the
principles of light reflection are important for
determining color mixtures and formulations. In
cleansing products it’s important to know about
physics of colloidal solutions and the mechanisms
of foam creation and dirt removal. For sunscreens,
the physics of energy absorption and reflection.
For all cosmetic products it’s helpful to know the
science of rheology. Fluid dynamics are also
important to understand as this relates to the
mixing and filling of large batches of cosmetics.
Biology
Since cosmetics are put on the biological surfaces, it is
helpful to know the basics of hair, skin and nail biology.
Cosmetic chemists learn about hair growth, the
composition of hair fibers, and the ways in which it is
damaged and repaired by personal care products. For
skin science cosmetic chemists need to understand
how the skin grows and the structure of the different
layers. It is also helpful to know some of the
biochemistry involved in creating skin as some raw
materials and cosmeceuticals are thought to interact
with biochemical mechanisms to improve the look and
feel of skin.
Cosmetics also have the potential to grow dangerous
microbes so formulators must spend time testing to
ensure contamination doesn’t happen. For this reason
it is important to learn about the growth habits of
bacteria, fungi, and other microbes that can infect
cosmetics.
Math
is the foundation of most any scientific subject. This
means being able to quickly figure out percentages and
convert units from mass to volume and visa versa.
While the math can get complicated the job mostly
involves straightforward calculations and avoids more
complex math like Calculus or Number Theory.
Marketing
Since cosmetic science is an applied science it also
involves topics that fall outside the realm of standard
physical sciences. This primarily involves product
marketing and market research.
Market research is a type of psychological research and
it focuses on figuring out what problems consumers
have and the types of products they want to solve
those problems. Marketing is also a psychological
study which focuses on figuring out how to
communicate with consumers and getting them a
message, which will prompt them to buy your
products.
Unlike other science-based industries, the cosmetic
industry is highly driven by marketing considerations.
Much of the basic cosmetic science technology has
been worked out and formulators spend their time
trying to incrementally improve existing products.
Future of cosmetic science
There are a number of technologies that promise
to have an impact on the future of cosmetic science
and formulation development. This includes
• 3D printing cosmetics which may have some
application in the color cosmetic area.
• Epigenetics – a field which activates DNA
sequences based on environmental conditions
• Microbial cleansing – using good microbes to
clean skin surface
• Sustainable sources – raw materials derived
from renewable resources like plants
10 COSMETIC PRODUCT FORMS
The basic categories for cosmetic formulas include
1.Solutions
2.Creams/Emulsions
3.Lotions
4.Ointments/Pastes
5.Suspensions
6.Tablets
7.Powders
8.Gels
9.Sticks
10. Aerosols
 1. Solution Cosmetics
These are the simplest type of cosmetic formulas and
are used for a wide range of products such as
shampoos, body wash, hand cleansers, colognes, etc.
They are homogeneous mixtures of soluble
ingredients. To make them you simply fill your
container with the main diluent (usually water) then
mix the rest of the ingredients into it. Sometimes
warming the system slightly will increase the speed at
which you can make them.
2. Creams / Emulsions
The majority of cosmetics use raw materials that are
not compatible so a cream or emulsion is used.
Emulsions are pseudo stable mixtures of immiscible
liquids dispersed in another liquid. They are used for
products like hand moisturizers, make up, hair
conditioners, sunscreens, etc. To create them you need
three formula components including an oil phase,
aqueous phase, and an emulsifier. The formulas are
made by heating up the oil and water phases
separately, mixing them together (along with the
emulsifier) when they are hot, and cooling them down
with thorough mixing. The result is a cream with tiny
particles of dispersed in the diluent phase.
3. Lotions
Creams are not always appropriate for some
applications because they can be too heavy or greasy.
In these cases, the lotion form is used. Lotions are
essentially thin creams. They are used for facial
moisturizers, leave-in hair conditioners, and
moisturizing cleansers. Since these are emulsions, you
make them the same way you would a cream. They are
generally easier because you do not have to worry
about the emulsion getting thick enough as it cools
down.
4. Suspensions
Suspensions are another product form for delivering
incompatible ingredients. Unlike creams, they are
typically clear products with visible particles like gelatin
beads or inorganic minerals (e.g titanium dioxide)
suspended throughout. They are used for sunscreens,
hand washes or shampoos. To create them you need
to include a polymer or clay that gives the formula
some internal suspending structure. Ingredients like
carbomer or bentonite clays are useful.
5. Ointments / Pastes
These are super thick products used for things like
hairdressing and medicated skin products. Usually,
they are anhydrous (contain no water) and are sticky &
greasy. Some common ingredients used to create
pastes include petrolatum, lanolin, or dimethicone.
Making them is a simple matter of heating up the raw
materials and rapidly mixing them until they are
dispersed.
6. Tablets & Capsules
Another product form that is often used for creating
color cosmetics is the tablet. These are physically
blended solids that are held together by being pressed
into shape. You’ll need special equipment to create
these products. They are also generally more
expensive.
7. Powders
One of the most common types of product forms for
color cosmetics is powders. Powders are also used for
products like baby powder & foot powder. They are
just mixtures of solid raw materials blended together
into a fine powder. Some typical ingredients include
talc, silicates, and starch. Special equipment is needed
when making these products as the fine powder can be
dangerous.
8. Gels
Another common form of cosmetic products is gels.
These are thick products, typically clear, and have a
property known as “shear thinning”. This means they
stay thick until you apply a force which makes them
thin and flowable. Gels are used for hair products, body
washes, shaving products, and in toothpaste. They are
made by using a gelling agent such as an acrylic
polymer, a natural gum or a cellulosic thickener.
9. Sticks
Sometimes you need to create a product that the
consumer won’t necessarily want to touch, for
example, lipstick or underarm deodorant. In these
cases you’ll use a stick product form. Sticks are solid
delivery forms that deliver active ingredients through a
rubbing action. The way you create them is by using
mostly materials that are solid at room temperature.
The ingredients are heated until they melt, mixed, and
poured into either a mold or the final container. When
they cool, they take the shape of their packaging.
 10. Aerosols
Aerosols are more of a packaging product form than a
specific formulation type. You could actually create an
aerosol out of almost any cosmetic formulation if you
have the right can, propellant, and nozzle set-up.
Aerosols are any cosmetic delivered from a pressurized
can. They are composed of a concentrate and a
propellant. You first make the formula as you would
any other cosmetic, then fill it into the can. You seal the
can and pressurize it using the appropriate propellant.
Recent VOC (volatile organic compounds) regulations
have reduced the use of aerosols in cosmetic products.
COSMETIC (GMP)
→ Cosmetic Good Manufacturing Practices (GMP)
relate to a set of comprehensive guidelines that help
cosmetic businesses consistently manufacture products
that are safe and of high quality. The word 'cosmetic' here
refers to goods or materials intended to alter, enhance,
cleanse, or groom one's face or body. They can range from
makeup and fragrances to products such as soap, lip
balms, shower gels, creams, lotions, body powders, and
hair products. Apart from cosmetics, Good Manufacturing
Practices also exist for other consumer products including
food, drugs, and supplements.
→ As its name implies, GMPs are concerned with
the manufacturing or production processes
that impact the safety, consistency,
and quality of the end product. Every cosmetic
business has a responsibility to ensure that
products created and ultimately sold are safe,
effective, and of consistently high quality. This
need is linked to various regulations that
govern the sale of cosmetic products. For
instance, in the US, the Federal Food, Drug and
Cosmetic Act (Section 301) enforced by the
FDA forbids the sale of cosmetic products that
are "adulterated" or "misbranded".
→ Safety refers to the prevention of
unintentional contamination, spoilage, or
misuse of final products that may cause
undesirable reactions and other health effects.
It can involve practices such as sourcing raw
materials from a reputable supplier, ensuring
facilities are cleaned appropriately, educating
staff about regular hand washing, and
proofreading labels before printing.
→ Consistency relates to the ability to control
manufacturing variables and processes so that
a consistent outcome is achieved each time.
For example, the formulation used, the types
of raw materials selected, the sanitation
protocols followed, and the technical ability of
the cosmetic chemist are just some of the
variables that can influence product quality.
Each, if not controlled, can lead to quality
variations from batch to batch. Creating
accurate and thorough documentation, and
then following them through, is vital in
reproducing product quality and achieving
consistency.
→ Quality relates to a product's ability to satisfy
certain criteria based on its attributes and
characteristics. The concept of 'quality' is often
operationalized and defined according to
objective requirements, such as color, odor,
viscosity, and pH. It also encompasses issues
such as safety and purity. GMP helps
companies manufacture products that are
consistently high in quality from batch to
batch.
COSMETIC GMP HELPS EMBED QUALITY INTO THE
ENTIRE MANUFACTURING PROCESS
→ GMP is a part of quality assurance which
ensures products are consistently produced
and controlled to quality standards
appropriate for their intended use. In this way,
cosmetic GMP embeds operational rules and
organizational guidelines into the entire
production process, allowing businesses to
continually enhance product quality while
saving the costs associated with making
production errors.
IS IMPLEMENTING COSMETIC GMP
MANDATORY?
→ In certain countries, GMP for cosmetics is
endorsed and highly encouraged by national
authorities but are not mandatory. In the US,
GMP is recommended for cosmetic businesses
 but it is not a legal requirement; this is why
FDA's cosmetic GMP guidelines emphasize
that their recommendations are 'non-binding'.
Similarly, in Canada, cosmetic businesses are
encouraged by Health Canada to follow GMPs
as set out by the ISO 22716 standard.
→ In other regions, however, GMP is a legal
requirement for cosmetic manufacturers. For
example, in Europe, the Cosmetics Regulation
(EC) 1223/2009 necessitates that any cosmetic
product aimed at selling to the EU market must
adhere to cosmetic GMP guidelines as outlined
by the ISO 22716.
BENEFITS OF FOLLOWING GMP FOR A SKINCARE
OR COSMETICS BUSINESS
→ Establishing GMPs can provide
cosmetics brands, including home or small businesses,
the security, and confidence needed to assure that their
products are safe. The benefits can also extend beyond
legal compliance; GMPs ensure you provide premium-
quality cosmetics that customers will love and be
satisfied with, increasing sales, boosting reputation, and
driving brand loyalty. Cosmetic GMP guidelines also
allow brands to carry out their own inspections of
current operations.
On the other hand, if GMPs are not implemented,
some of the issues cosmetic businesses could
run into include:
→ Mix-ups in labels or cosmetic ingredients
and other production errors.
→ Equipment and tools getting
contaminated.
→ Staff unintentionally introducing germs
into the facility (e.g. by working with an
open wound, not using a hairnet, and so
on).
→ Raw materials (including water) not
getting tested adequately for quality
before use.
→ Difficulty replicating manufacturing
procedures due to lack of documentation,
leading to unnecessary deviations in
quality.
→ Printing labels containing errors,
misinformation, and/or not having the full
required information.
→ Selling products that are unintentionally
harmful or hazardous, causing health
issues or adverse skin reactions.
→ Difficulty tracing and identifying potential
issues that are causing customer
complaints.
THE ROLE OF ISO 22716 IN COSMETIC GMP
→ The ISO (International Organization for
Standardization) is a non-governmental
body that sets forth many internationally
accepted standards across a wide range of
industries. In 2007, the International
Cooperation on Cosmetic Regulation
(ICCR), formed by the US, Canada, EU, and
Japan, decided that they would use this
standard when recommending or
publishing cosmetic GMP guidelines for
each nation. The ISO 22716 guidelines,
therefore, form the bedrock of cosmetic
GMP when it comes to international
standards.
→ In 2013, the FDA published its updated
GMP guidelines, taking into account the
recommendations stated in ISO 22716.
AN OVERVIEW OF COSMETIC GOOD
MANUFACTURING PRACTICES GUIDELINES
1. Documentation & Records
→ The process of documentation refers to the act
of writing down the many facets of how
something is carried out or conducted. The
resulting document can be called a 'record' or
collectively referred to as 'documentation'.
Cosmetic GMP emphasizes the importance of
capturing all production processes and
workflows in writing, whether that is in paper
or electronically.
→ Not only should documentation exist to guide
what must be done, records should also be
created to capture what was done each time a
specific batch is created. When issues arise,
 the maintenance of accurate records helps
businesses quickly identify what went wrong
and why. It also provides evidence that GMPs
are being followed.
Cosmetic businesses may want to consider the
following:
→ Have you documented all of your production
operations, processes, and practices?
→ Do you create records or logs for all your
production activities?
→ Do you create records of all ingredients or raw
materials (such as their unique codes,
quantities, and lot numbers) that get
incorporated into each batch?
→ Are you keeping appropriate and timely
backups of your documentation?
→ Are your records sufficient to carry out a
prompt recall of a product if needed once it is
in distribution?
2. Buildings & Facilities
→ The operational premises of a cosmetic
business should offer a clean, safe, hygienic
environment that minimizes the risk of
contamination. The facilities should be
organized in a methodical way (e.g. there
should be an adequate division of production,
storage, and packing activities), and there
should be appropriate cleaning, sanitization,
and pest control protocols in place.
Cosmetic businesses may want to consider the
following:
→ Is your workspace organized in a way that
prevents possible mix-ups or contamination?
→ Are building equipment and facilities such as
plumbing, and heating working appropriately
and maintained periodically?
→ Is your workspace (including tables, floors,
ceilings, and other surfaces) made of a material
that can be readily cleaned and sanitized?
→ Do you ensure that only authorized personnel
enter your production facility?
3. Equipment Used
→ All equipment used, such as bowls, utensils,
and measuring tools should be clean and
prevent the adulteration of finished cosmetics
with foreign material, dirt, or cleaning
products. They should be stored properly and
calibrated periodically if needed. If broken or
no longer suitable for use, they should be fixed
or replaced.
Cosmetic businesses may want to consider the
following:
→ Are you using equipment that is proper and
suitable for its purpose?
→ Are you using equipment that is clean and
sanitary?
→ Are your scales and other relevant equipment
calibrated regularly?
→ Is your equipment checked periodically to
ensure they are working correctly?
4. Personnel
Cosmetic GMP highlights the importance of ensuring
that employees are adequately trained, experienced,
and qualified so that their behavior contributes to
safety and quality rather than compromising it. They
should also have the necessary backing from the
company (in the form of training, supervision,
education, resources, safety equipment, and so on) to
perform their job appropriately and with cleanliness.
Cosmetic businesses may want to consider the
following:
→ Are you or your employees in charge of
manufacturing and quality control well-trained
to carry out their job tasks and responsibilities?
→ Are you or your employees equipped with the
materials/resources necessary to perform jobs
safely and hygienically?
→ Are you or your employees practicing good
hygiene, for example, wearing a hairnet,
protecting the workspace from open cuts or
wounds, and practicing handwashing?
→ Have you appointed a sufficient number of
employees to supervise the overall (and
aspects of) the production process?
5. Raw Materials
All raw materials should be organized and labeled with
relevant identifiable information (name, lot number,
and control status) so that they can be traced at any
point in the manufacturing process. Additional
guidelines are stated for water, color additives, and
restricted cosmetic ingredients.
Cosmetic businesses may want to consider the
following:
→ Are your raw materials stored appropriately to
prevent spoilage or deterioration?
→ Are your raw materials labeled clearly and
accurately?
→ Do you have processes in place to verify that
the water incorporated in your products is
clean, hygienic, uncontaminated, and of a
certain quality (e.g. distilled or deionized)?
6. Production Process
Appropriate documentation and records should be
created to capture all aspects of the production
process. The guideline recommends establishing
Standard Operating Procedures (SOPs) for all
processes. An SOP is simply a clearly written
instructional document that clarifies in detail how a
specific production activity is conducted.
Cosmetic businesses may want to consider the
following:
→ Is your production process outlined or
mapped out in detail?
→ Do you create records for each batch you
produce, including details such as the
formulation, raw materials, and equipment
used, procedures followed, and a unique
batch number?
7. Laboratory Controls
Cosmetic GMP emphasizes that testing should be
conducted for raw materials, in-process samples, and
finished product samples to see if they comply with
relevant quality criteria and specifications. While
complete laboratory testing may not be feasible for
smaller cosmetic businesses, it is important to have
protocols in place that allow raw materials and finished
products to be regularly examined for issues such as
contaminants or purity.
Cosmetic businesses may want to consider the
following:
→ Do you keep samples of received shipments
and finished products so that they can be
tested or observed again for compliance?
→ Do you carry out testing to ensure the
effectiveness of preservative systems used?
8. Internal Audit
The purpose of conducting an internal audit is to
evaluate the overall performance of a quality
management system. It should be able to identify the
system's strengths and weaknesses, as well as advise a
plan of action to overcome failings in GMP. A good
internal audit should be unbiased and strive towards
continuous improvement through rigorous self-
reflection.
Cosmetic businesses may want to consider the
following:
→ Do you have an internal audit plan or checklist
that can accurately identify the current
performance, strengths, and weaknesses of
your GMPs?
→ Does this plan include a follow-up that
corroborates and records the improvements
made as a result of the audit?
9. Complaints, Adverse Events, and Recalls
→ Any complaints or adverse events reported on
a particular product should be recorded and
evaluated thoroughly. This review process
should be documented using Standard
Operating Procedures (SOPs) and applied to
both written and verbal complaints.
→ A systematic complaint logging and review
process helps businesses hone in on the source
of those events, in turn recognizing potential
issues with safety or quality. For instance, a
complaint regarding the odor or color of a
product can flag a possible issue with spoilage
or contamination. Similarly, a complaint about
an incorrect label could signal a possible mix-
up that could be affecting other products
within a batch. Adverse events, which include
complaints of undesired bodily reactions in
response to the product, should be evaluated
with extra care.
 → If a severe or high-risk safety or quality issue is
suspected, a company may conduct a total
product recall. Again, relevant documentation
should be created to ensure there is a
systematic plan of action that could lead to a
swift and efficient product recall.

Cosmetic businesses may want to consider the

following:
→ Do you have SOPs in place for logging and
reviewing of all complaints? Do these
documents enable you to identify and take
action against possible quality or safety
issues?
→ Do you have an SOP in place for product
recalls? Does this document enable you to
identify and execute a prompt recall of a
specific batch once it is in distribution?

COSMETIC GMPs ARE MINIMUM STANDARDS

→ A final thought is that GMP recommendations

are considered to be minimum standards, not
an ultimate goal. Businesses should, therefore,
aspire to exceed GMP standards and not just
meet them.

→ It may also be useful to remember that GMP

should be viewed as a valuable resource rather
than a daunting rule book. By implementing its
practices, businesses will be able to
manufacture high-quality cosmetic products
consistently and with confidence.