ORIGINAL ARTICLE

The influence of the amount of sunscreen applied and its sun protection
factor (SPF): evaluation of two sunscreens including the same ingredients
at different concentrations
Sergio Schalka, Vitor Manoel Silva dos Reis & Luis Carlos Cucé
Department of Dermatology, Hospital das Clı́nicas, University of São Paulo, Sao Paulo, SP, Brazil

Summary

Key words: Background: To estimate labeled sun protection factor (SPF) for sunscreen, the amount of
photoprotection; sun protection factor; product applied on volunteers, according to food and drug administration (FDA) and
sunscreen International protocols, is 2 mg/cm2. However, different studies have shown that consumers
actually apply much less product when exposed to the sun. Previous studies have reported
Correspondence: contradictory findings in an attempt to correlate the amount applied in relation to SPF. The
Sergio Schalka M.D., Department of Dermatology, objective of the present study was to estimate the influence of the quantity of sunscreen
Hospital das Clı́nicas, University of São Paulo, Av. Dr.
applied in the determination of SPF, according to the FDA methodology.
Enéas Carvalho de Aguiar 255, # 3070/05403-
Subjects and methods: Forty volunteers were included in two groups (SPF 15 and 30). The
000 – Sao Paulo – SP, Brazil.
Tel: 155 11 3683 4995
selected sunscreen was then applied in four different quantities (2, 1.5, 1.0 and 0.5 mg/cm2).
Fax: 155 11 3681 6362 All areas were irradiated with a solar simulator. After 24 h, the minimal erythemal dose (MED)
e-mail: medci004@terra.com.br and SPF were determined.
Results: In both groups, we observed that the SPF decreased when the amount of sunscreen
Accepted for publication: applied was decreased. The differences between the 2 mg/cm2 area and the others were
10 October 2008 significant in both groups (P o 0.001). The correlation between specified SPF and applied
amount grew exponentially.
Conflicts of interest: Conclusion: The protection provided by sunscreen is related to the amount of product applied.
None declared. It is essential to educate consumers to apply larger amounts of sunscreen for adequate
photoprotection.

S unscreen use is considered one of the most important photo-

protective actions for preventing skin cancer. Health
authorities around the world suggest regular use of sunscreen
been investigated in different studies. Based on a theoretical
model (11), the relation between the amount applied and SPF
has been suggested to be exponential. An in vivo study (12),
during sun-exposed activities such as working, outdoor sports performed according to the International Sun Protection Factor
and beach exposure (1). Test Method (3) evaluating three commercial sunscreens (labeled
The sun protection factor (SPF) is the most popular method SPF ranging from 20 to 25), proposes a linear relation between
for sunscreen evaluation and measures the efficacy of a sun- SPF and applied amount.
screen in preventing sunburn, based on the relation of the
minimal erythemal dose (MED) of the protected skin (protected
by 2 mg/cm2 of the tested product) and the unprotected skin. Objective
There are two main methodologies used worldwide to
The present study aimed to investigate, for the first time, the
calculate labeled SPF of sunscreens: The Food and Drug
relation between the amount applied of two sunscreens including
Administration (FDA) monograph (2) and the International Sun
the same ingredients at different concentrations (labeled SPF 15
Protection Factor Test Method (3). They are similar in most
and SPF 30) and SPF, according to the FDA methodology (FDA
aspects and differ mainly in the number of subjects and the
final monograph – 1999) (2).
calculation of the final SPF number.
On the other hand, many studies (4–10) have shown that
users apply much less sunscreen during leisure time than the
Subjects and methods
suggested 2 mg/cm2, ranging from 1.3 to 0.39 mg/cm2.
The influence of the amount applied on the efficacy of the Before the selection of volunteers, this protocol was approved by
sunscreen in preventing sun damage – mainly sunburn – has the Ethical Committee, University of Sao Paulo, according to

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Schalka et al.

Brazilian regulations on clinical research studies (Resolution 196/
96), Good Clinical Practices (GCP) and Helsinki Declaration.
Subjects
Forty volunteers, 36 women, and four, men participated in this
study. All signed an Informed Consent form before the study. The
age of the subjects varied from 18 to 51 years, with a mean
of 33.5 years.
Volunteers were randomized into two different groups
according to the SPF they would receive: SPF 15 and SPF 30.
Figure 1 shows the distribution of subjects according to
Fitzpatrick’s classification.
Before the study, and according to Fitzpatrick’s classification,
subjects were subjected to five different UV doses, in geometrical
progression, varying 25% from each other, to determine the
effective individual MED, defined as the first perceptible redness
reaction with clearly defined borders. An erythema reading was
made 24 h after exposure. For these results to be acceptable, at
least one sub-site had to be erythema-free; otherwise, smaller UV
doses were required.
titanium dioxide, octyl metoxicinnamate and bis-ethylhexyl-
oxyphenol methoxiphenol triazine (Tinosorb Ss, Basel,
Switzerland).
The standard sunscreen used was a homosalate sunscreen
as described in the FDA monograph, produced and certified
by Cosmetech Laboratories (Fairfield, NJ, USA) with a labeled
SPF of 4.57.
The products were weighed using a syringe and an analytical
scale, considering the quantities described above.
The products were applied to the predetermined sites using a
finger cot, carefully spread on the area.
Procedures
Six different 50 cm2 areas were marked on the back of subjects:
Area 1 – Unprotected skin;
Area 2 – Standard sunscreen – 2 mg/cm2 (100 mg);
Area 3 – Product – 2 mg/cm2 (100 mg);
Area 4 – Product – 1.5 mg/cm2 (75 mg);
Area 5 – Product – 1.0 mg/cm2 (50 mg);
Area 6 – Product – 0.5 mg/cm2 (25 mg).

Radiation source The areas were randomized and the person responsible for the
randomization and application (operator) was different from the
The UV source was a 601–300 W Solar Simulator produced by one responsible for the erythema reading (one of the authors).
Solar Light Co. (Glenside, PA, USA). The equipment uses a 300 W
Xenon Arc lamp that emits UV radiation in the region of  Unprotected skin
290–400 nm and meets the FDA spectral irradiance standard
Five different UV doses were applied to the predetermined
(periodically measured with a calibrated spectroradiometer
unprotected area, in a geometrical progression of 1.25, as follows:
system). The unit has different ports (liquid light guides), with
0.64 MEDi, 0.8 MEDi and 1 MEDi, 1.25 MEDi, 1.56 MEDi, where:
different adjustable outputs.
The radiometers and dose control system used in this study
MEDi ¼ Individual Minimal Erythemal Dose;
were also produced by solar light. All calibrations were
found in the pre-test described above
performed according to NIST traceable standards.

Tested products  Protected areas

Two different commercially available sunscreens were selected
for this study, labeled SPF 15 and SPF 30, produced by the same
company and under the same brand name (Sundowns SPF 15
and Sundowns SPF 30; Johnson & Johnson, São José dos
campos, Brazil), with the following UV filter combination:
15 min after application of the tested products, each protected
area was exposed to seven different UV doses: 0.76X, 0.87X,
0.93X, 1.00X, 1.07X, 1.15X and 1.32X, where:
X ¼ MEDi multiplied by expected SPF

Subjects - Phototype
16
14 I Erythema reading (MED) and individual SPF calculation
12 II
10 The erythema response, MED was evaluated 24 h after exposure
III
8 using a fluorescent lamp emitting 450–550 lux, whose spectrum
6 complies with the D65 illuminant. The lamp was used to control
4
the lighting level of the room for a standard reading of erythema.
2
0 Individual SPFs were calculated using the following equation:
SPF 15 SPF 30
Group SPF = MED protected skin/MED unprotected skin

Fig. 1. Distribution of subjects according to skin phototype. Phototype The mean, standard deviation, standand error (A) and the
according to the Fitzpatrick classification. Number of subjects per group, 20. final SPF were then calculated according to FDA procedures.

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 The influence of the amount of sunscreen applied and its SPF

Data analysis Despite the high adjusted R2 (80.9%) and significant coeffi-
cients, the linear model violated the suppositions of independence
To compare SPF of the different amounts applied, we used a
and equality of variance (homocedasticity) and, according to the
Wilcoxon test for paired data.
linearity test (lack-of-fit test), we verified that the relation between
Regression analysis was used to evaluate the relationship
the variables is not linear (P-value o 0.001); consequently, it was
between SPF and the independent variables (amounts applied
necessary to apply a logarithmic transformation to the response
and labeled SPF). Given that in the regression analysis the results
variable and adjust a new model:
showed a nonlinear relation (lack-of-fit test), the logarithmic
transformation was applied in the response variable (SPF) and a ln (SPFi) = Qty
new regression model was fitted.
where:

Results SPFi ¼ Individual Sun Protection Factor;

i:e:; the expected value of SPF for each
The 40 volunteers completed the study and none of them
presented any adverse reaction during the study. user
Tables 1 and 2 show the results of SPF studies in the different
Qty=Applied quantity of the sunscreen
groups and the different amounts applied, following the FDA
methodology. In this new model, we excluded the intercept, because when
As expected, in both groups, the SPF decreased when the sunscreen is not applied (Quantity = 0), the SPFi should be
the amount of sunscreen applied was decreased. According to close to 1; then, to adjust the model to represent this result, we
the Wilcoxon test, the differences between the 2 mg/cm2 area cannot have an intercept (ln(1) = 0). Tables 3 and 4 present the
and the others were significant in both groups at a significance data related to linear and exponential models, respectively.
level of 5% (P value o 0.001). Table 5 shows the results of the study and a comparison with
We constructed a multiple linear regression model to verify the calculated values according to the linear and exponential
the linear relationship between the dependent variable Individual models.
SPF (SPFi) and the independent variables labeled SPF and quantity Based on these results, we concluded that the two dependent
applied (Qty). variables (SPF and quantity) have statistically significant coefficients,
and the predictors explain 99% of the variability of individual SPF.
Table 1. Final SPF number related to the amount applied – Group SPF 15 Figure 2 shows that the exponential model is more convenient
to explain the relation between SPF and the applied amount.
Mean Standard Standard CI Final
Amount applied SPF deviation error (A) 95% SPF
2 mg/cm2 17.65 2.68 1.26 7.12 16 Table 3. Linear regression model
1.5 mg/cm2 11.87 1.73 0.81 6.81 11
1.0 mg/cm2 7.23 1.23 0.58 7.96 6 Dependent Standard
0.5 mg/cm2 5.1 0.91 0.43 8.37 4 variables Coefficient error T P value
Standard sunscreen 4.72 0.73 0.34 7.27 4
(2 mg/cm2) Intercept  10.398 1.068  9.73 o 0.001
SPF 0.447 0.037 12.17 o 0.001
Number of volunteers: 20. Quantity applied 11.318 0.493 22.94 o 0.001
Final SPF = Largest whole number less than (mean SPF – A) using R2-adjusted = 80.9%.
the upper 5% point from Student’s t-distribution table with n1 linearity test: P_value o 0.001.
degrees of freedom.
Adjustment of the linear regression model of the SPFi according to
the dependent variables Intercept, SPF and quantity applied.
T value from paired t-test.
Table 2. Final SPF number related to the amount applied – Group SPF 30

Amount applied Mean Standard Standard CI Final

(mg/cm2) SPF deviation error (A) 95% SPF
Table 4. Logarithmic regression model
2 30.09 5.17 2.42 8.05 27
1.5 17.58 2.96 1.39 7.89 16
1.0 13.07 2.51 1.18 9.01 11 Standard
0.5 7.96 1.66 0.78 9.75 7 Dependent variables Coefficient error T P value
Standand Sunscreen 4.49 0.80 0.37 8.32 4 SPF 0.0503 0.00167 30.23 o 0.001
(2 mg/cm2) Quantity applied 1.0329 0.02885 35.81 o 0.001
R2-adjusted = 99.0%.
Number of volunteers: 20
Final SPF = Largest whole number less than (Mean SPF – A) using
Adjustment of the linear regression model of the SPFi according to
the upper 5% point from Student’s t-distribution table with n1 the dependent variables SPF and quantity applied.
degrees of freedom. T value from paired t-test.

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Schalka et al.

Table 5. Relation between SPF and amount applied: measured and calculated values (exponential and linear fit models)

Labeled Amount of sunscreen

SPF applied (mg cm  2) 0.5 1 1.5 2
15 measured values 5.1 7.23 11.87 17.65
calculated value (linear fit) 1.97 (0.91–3.03) 7.63 (6.82–8.44) 13.29 (12.48–14.10) 18.95 (17.89–20.01)
calculated value (exponential fit) 3.56 (3.46–3.67) 5.97 (5.81–6.17) 10.01 (9.58–10.49) 16.78 (15.64–18.17)
30 measured values 7.96 13.06 17.57 30.08
calculated value (linear fit) 8.68 (7.62–9.75) 14.34 (13.53–15.15) 20 (19.19–20.81) 25.66 (24.60–26.72)
calculated value (exponential fit) 7.58 (7.03–8.17) 12.70 (12.06–13.46) 21.29 (20.29–22.42) 35. 69 (33.78–37.71)

Measured values founded in the study.

Calculated value (linear fit): SPFi (CI 95%) = (0.447SPF (label)111.318Qty) – 10.398.
Calculated value (exponential fit) = SPFi (CI 95%) = e0.0503SPF (label)11.0329Qty.

SPF Exponencial fit Linear regression

40.00

30.00

30.00
SPF

20.00

10.00

SPF - Label
0.00

40.00

30.00

15.00
SPF

20.00

10.00

0.00

0.50 0.75 1.00 1.25 1.50 1.75 2.00

Sunscreen Quantity mg/cm2

Fig. 2. Relation between sun protection factor (SPF) and applied amount of sunscreen SPF 15 and SPF 30. Linear regression: SPFi = (0.447SPF
(label)111.318Qty) – 10.398. Exponential fit: SPFi = e 0.0503SPF(label)11.0329Qty.

In conclusion, there is an exponential relation between labeled
SPF and the amount applied, and the following equation may be
used to estimate individual SPF (bearing in mind that this model
was adjusted considering the tested products, with a labeled SPF
15 and SPF 30):
 SPFðlabelÞþ1:0329 Qty
SPFi ¼ e0:0503
Discussion
In recent decades, the use of sunscreen has been encouraged by
health authorities and dermatologists worldwide to help prevent skin
cancer (mainly non-melanoma skin cancer) (1) and photoaging.
According to the International Agency for Research on Cancer
(IARC) (13), despite inadequate evidence that sunscreens play a
preventive role against basal cell carcinoma or malignant
melanoma and only limited evidence that sunscreens prevent
squamous cell carcinoma, the use of sunscreens should be
considered as part of an overall sun protection program.
The development of new photostable UV filters, capable
of absorbing UVA and UVB, has improved the efficacy and
safety of the new products.
On the other hand, to achieve the labeled photoprotection
(i.e. SPF), these products must be applied, according to inter-
national methods (2, 3), in an amount of 2 mg/cm2.
However, different studies (4–10) have shown that users apply
much less than this, when intentionally exposed to the sun,
because of the sticky sensation caused by a thick layer and
obviously because of higher costs.
The relation between the thickness of the sunscreen applied
and the SPF has been discussed previously.
Based on a mathematical model, Wulf et al. (11) suggested that
SPF would drastically decrease when applied in thinner layers.
However, these findings considered uniform application on a flat
surface, which is not the case of human skin.
Recently, Wulf et al. (14), in an in vivo study with 20 volunteers
using a broadband UVB unit, showed an exponential relation

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between the informed SPF and the quantity applied of a
sunscreen labeled SPF 4. The use of a broadband UVB unit
rather than a Solar simulator does not meet FDA or International
SPF protocols, because of different emission spectrum.
Bimczok et al. (12), together with a DGK task force, designed a
multicenter study to investigate the relation between the amount
applied and the SPF of three different sunscreens (labeled SPF
ranging from 20 to 25), following the International Sun Protection
Test Method (3).
The authors concluded that there was a linear correlation
between the amount applied and the SPF in the three products,
with different coefficients.
For the first time, we carried out an in vivo study strictly following
the FDA monograph methodology to compare labeled SPF and
different applied amounts of two products with different SPF: SPF
15 and SPF 30. We chose to follow the FDA protocol in order to
have a larger group of volunteers in one center for the same product.
Our results showed a significant exponential relation between
SPF and the amount of sunscreen applied, with an equation
capable of calculating the individual SPF according to the labeled
SPF and the quantity applied, in both the groups studied
(sunscreen SPF 15 and SPF 30).
Despite the exponential relation, our results are different from
the theoretical calculations, which suppose a dramatic reduction
in the SPF with the reduction of the thickness of the applied
sunscreen. In fact, our results are closer to the linearity than to
the exponential relation expected when Beer’s Law is applied.
Assuming the skin to be perfectly flat and non-absorbent and
the sunscreen an absorbing and non-scattering medium,
Beer–Lambert’s law would apply and the logarithm of the SPF
would be directly proportional to the applied thickness (4).
Of course, this is not the case: the skin is not a flat surface and
the sunscreen applied on the skin tends to accumulate in the
sulci, leaving the epidermal ridges partially unprotected. It can be
estimated (15) that the volume required to fill the grooves
responsible for the primary epidermal surface lines on 1 cm2
lies in the range of 1–2 ml.
In smaller amounts, the epidermal ridges are unprotected,
regardless of the amount of sunscreen applied.
Because this occurs, the reduction of the thickness of the film
decreases the protection on the skin surface, exposing more areas
closer to the valleys, meanwhile still exposing the heights.
This may explain why Beer’s law is not valid in the in vivo SPF
method, and the reduction of the SPF according to the reduction
of the applied thickness is not as dramatic as supposed, providing
results closer to linearity, as found in our study.
The results found in our study may also explain why many
users do not receive appropriate protection from sun damage
(especially sunburns), even despite using high-SPF sunscreen.
If consumers do not receive the protection expressed on the
label of the sunscreen, two possibilities may be considered:
changing the methodologies so that the products can be tested
with smaller quantities of sunscreen or encouraging users to
apply more sunscreen when outdoors.
The results obtained by Bimczok et al. (12) have shown that
2 mg/cm2 is necessary to achieve good reproducibility of the
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The influence of the amount of sunscreen applied and its SPF
method, with the lowest confidence interval compared with
smaller amounts of sunscreen applied. Considering this, changing
the quantity of sunscreen applied in SPF test methods is not a
desirable alternative.
In addition to this, the modern concept of the SPF is not to
offer an exact number but to provide classes of protection and
help the consumers to compare products.
Consequently, we consider it necessary to run public health
campaigns encouraging people to apply larger amounts of sun-
screen when exposed to the sun.
According to FDA, in the Proposed Amendment of Final
Monograph (16), the inclusion in the directions of the sunscreen
product of terms such as apply ‘liberally’ or ‘generously’ will help
reduce underapplication by consumers.
In conclusion, this study shows that there is an important
correlation between the applied quantity of sunscreen and its
efficacy, and this relation is demonstrated in exponential growth.
More studies must be carried out to determine adequate
photoprotection measures, with a greater number of sunscreens
evaluated and more centers included, to verify whether the
exponential relation between the amount applied and the SPF,
verified in this study, holds for other sunscreens.
Acknowledgement
Thanks are due to Dr Henry W. Lim (Henry Ford Health System,
Detroit, MI, USA) for critically reading the manuscript and for
helpful suggestions.
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