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High-SPF sunscreens (SPF >= 70) may provide ultraviolet protection above
minimal recommended levels by adequately compensating for lower
sunscreen user application amounts

Article in Journal of the American Academy of Dermatology · March 2012

DOI: 10.1016/j.jaad.2012.02.029 · Source: PubMed

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 High-SPF sunscreens (SPF $ 70) may provide
ultraviolet protection above minimal recommended
levels by adequately compensating for lower
sunscreen user application amounts
Hao Ou-Yang, PhD,a Joseph Stanfield, MS,b Curtis Cole, PhD,c Yohini Appa, PhD,a and Darrell Rigel, MDd
Los Angeles, California; Winston Salem, North Carolina; Skillman, New Jersey; and New York, New York

Background: The manner in which consumers apply sunscreens is often inadequate for ultraviolet
protection according to the labeled sun protection factor (SPF). Although sunscreen SPFs are labeled by
testing at an application density of 2 mg/cm2, the actual protection received is often substantially less
because of consumer application densities ranging from 0.5 to 1 mg/cm2. High-SPF sunscreens may
provide more adequate protection even when applied by consumers at inadequate amounts.

Objective: We sought to measure the actual SPF values of various sunscreens (labeled SPF 30-100) applied
in amounts typical of those used by consumers.

Methods: Actual SPF values were measured on human volunteers for 6 sunscreen products with labeled
SPF values ranging from 30 to 100, applied at 0.5, 1.0, 1.5, and 2.0 mg/cm2.

Results: There was a linear relationship between application density and the actual SPF; sunscreens with
labeled SPF values of 70 and above provided significant protection, even at the low application densities
typically applied by consumers. Sunscreens labeled SPF 70 and 100 applied at 0.5 mg/cm2 provided an
actual SPF value of, respectively, 19 and 27.

Limitations: The study was conducted in a laboratory setting under standardized conditions and results
are extrapolated to actual in-use situations.

Conclusion: Sunscreens with SPF 70 and above add additional clinical benefits when applied by consumers
at typically used amounts, by delivering an actual SPF that meets the minimum SPF levels recommended for
skin cancer and photodamage prevention. In contrast, sunscreens with SPF 30 or 50 may not produce
sufficient protection at actual consumer usage levels. ( J Am Acad Dermatol 2012;67:1220-7.)

Key words: minimal erythema dose; sun protection; sunburn; sunburn protection factor; sunscreens;
ultraviolet protection.

importantly, to immunosuppression2 and skin can-

T
not
he harmful effects of ultraviolet (UV) radia-
tion on the skin have been known for quite
some time. Exposure to UV radiation leads
only to skin photodamage1 but, more
cers3 such as squamous cell carcinoma,4 basal cell
carcinoma,5 and melanoma.6,7 To reduce the inci-
dence of UV-related skin cancers, the American

From Neutrogena Corp, Los Angelesa; Suncare Research Labora- conducting this study, and he is currently a consultant to
tories LLC, Winston Salemb; Johnson and Johnson Consumer Galderma Laboratories LP. Dr Rigel is a consultant for Neu-
Companies, Skillmanc; and New York University Medical trogena Corp, Johnson and Johnson Consumer Companies,
Center.d Beiersdorf, and P&G.
Funded in full by Neutrogena Corp; the preparation of this Previously presented as a poster at the 69th American Academy of
manuscript was sponsored in full by Johnson and Johnson Dermatology Annual Meeting, New Orleans, Feb. 4-8, 2011.
Consumer Companies. Accepted for publication February 17, 2012.
Disclosure: Drs Ou-Yang and Appa are employees of Neutrogena Reprint requests: Hao Ou-Yang, PhD, Neutrogena Corp, 5760 W 96
Corp, the manufacturer of two of the sunscreens tested. Dr St, Los Angeles, CA 90045. E-mail: [email protected].
Cole is an employee of Johnson and Johnson Consumer Published online April 1, 2012.
Companies, a sister company of Neutrogena Corp. Mr Stanfield 0190-9622/$36.00
is an employee of Suncare Research Laboratories, the inde- Ó 2012 by the American Academy of Dermatology, Inc.
pendent testing laboratory that received compensation for doi:10.1016/j.jaad.2012.02.029

1220
J AM ACAD DERMATOL Ou-Yang et al 1221
VOLUME 67, NUMBER 6

Academy of Dermatology recommends, among users, to determine if high-SPF products applied per
other measures, the generous application of a consumer behavior would still yield an SPF adequate
‘‘broad-spectrum, water-resistant sunscreen with for skin cancer prevention,26 compared with lower
sun protection factor (SPF) of at least 30 to all SPF products.
exposed skin.’’8
Many studies have shown that sunscreens can METHODS
protect from UV-induced damage and skin cancer.9-12 This study evaluated the effects of various appli-
The determination of their cation densities on the actual
SPF value is regulated by SPF values of 6 sunscreen
the Food and Drug CAPSULE SUMMARY products, with labeled SPFs
Administration (FDA) and ranging from 30 to 100. The
d Consumers typically apply sunscreens
other internationally recog- investigation was designed
unevenly and in amounts lower than
nized testing standards, with a 2-step approach. An
recommended, reducing the actual
which all dictate that sun- initial study (study A) was
sunburn protection factor.
screens be tested at an appli- conducted on 251 volunteers
cation density of 2 mg/ d Sunscreens with sun protection factor of to determine the SPF value of
cm2.13,14 However, several in- 70 and above yield significant protection 6 sunscreens (labeled SPF
vestigations have shown that even when underapplied in typical from 30-100) at 4 different
consumers typically apply consumer use situations. application densities (0.5,
less than 2 mg/cm2,15-20 thus d Sunscreens with sun protection factor of 1.0, 1.5, and 2.0 mg/cm2).
reducing the actual protec- 70 and above may deliver the minimal The second study (study B),
tion of the sunscreen.21-23 In SPF levels for skin cancer and conducted on 76 volunteers
an open study conducted at photodamage prevention, even when after the results of study A
the beach on 42 volunteers, misused or under-applied. were reviewed, was carried
Bech-Thomsen and Wulf15 out to compare the SPF
calculated that the average values of the 6 sunscreens
sunscreen density applied by sunbathers was 0.5 at low application densities (0.5 and 1 mg/cm2) side
mg/cm2. Another group assessed the amount of by side.
sunscreen applied by 10 women with photosensitive Both studies were single center, controlled, ran-
skin conditions, as they would use it during a sunny domized, and evaluator blinded. Subjects were
day; they found that the median application dose was male/female healthy volunteers with Fitzpatrick
0.5 mg/cm2, with site variations from 0 to 1.2 mg/ skin types I, II, and III.27 To facilitate estimation of
2 16 17
cm . Grosick and Tanner reported a study in the minimal erythema dose (MED), colorimetric
which 700 women were given free access to various measurements of each subject’s skin were obtained
sunscreens SPF 15 and higher to be used over 3 to 6 according to the international SPF method, and the
weeks; the study found that the SPF achieved in actual individual typology angle value was computed.14
use was below that of the labeled SPF. Investigations Both studies were conducted in accordance to the
on sunscreen application by beachgoers have further FDA final monograph on sunscreen products13,28
confirmed that consumers rarely apply sunscreens and to the Declaration of Helsinki principles; proto-
uniformly and usually do not reapply them often cols and informed consent were approved by an
enough, particularly after swimming.18,19 independent institutional review board.
In 2011, the FDA proposed to cap the labeled SPF
at ‘‘501,’’ stating that there is insufficient evidence Test sunscreen formulations and test sites
that SPF values above 50 produce additional clinical Six US-marketed sunscreen formulations were
benefits.24 However, a consumer in-use study con- tested (4 lotions and two sprays). The 4 lotions
ducted to compare the efficacy of a sunscreen with were selected based on similar vehicles and types of
SPF 50 versus one with SPF 85 demonstrated that the active ingredients. The two sprays also contained
higher SPF sunscreen provided better sunburn pro- similar types of active ingredients. The test products
tection.25 In addition, it is widely presumed that were:
high-SPF sunscreens may deliver an SPF adequate (A) SPF 30 lotion sunscreen (Coppertone Sport 30,
for skin cancer and photodamage prevention even SPF 30, Schering-Plough HealthCare Products
when underapplied by consumers. Inc, Memphis, TN).
The purpose of this study was to test the actual (B) SPF 100 lotion sunscreen (Neutrogena Ultra
SPFs of sunscreens with labeled SPFs 30 to 100 under Sheer Lotion SPF 100, Neutrogena Corp, Los
the reduced densities that are typically applied by Angeles, CA).
1222 Ou-Yang et al J AM ACAD DERMATOL
DECEMBER 2012

sources were calibrated using spectroradiometric

Abbreviations used:
measurements (model OL756 spectroradiometer,
FDA: Food and Drug Administration Optronic Laboratories, Orlando, FL) and were found
MED: minimal erythema dose
SPF: sunburn protection factor to meet the specifications for UV spectral distribution
UV: ultraviolet outlined in the FDA proposed amendment to the
sunscreen monograph13 and the international SPF
method.14
(C) SPF 100 spray sunscreen (Neutrogena Ultimate
Sport Spray SPF 100, Neutrogena Corp, Los Procedures
Angeles, CA). A total of 251 volunteers were enrolled in study A
(D) SPF 50 lotion sunscreen (Coppertone Sport and 76 volunteers were enrolled in study B. Study B
501, SPF 501, Schering-Plough HealthCare was conducted after reviewing the results from study
Products Inc, Memphis, TN). A. Both studies followed the same procedures be-
(E) SPF 50 spray sunscreen (Coppertone Sport 50 low, except where indicated.
Continuous Spray, SPF 501, Schering-Plough Day 1eMED determination. On day 1, 5 UV
HealthCare Products Inc, Memphis, TN). doses, progressively increasing by 25% increments,
(F) SPF 70 lotion sunscreen (Coppertone Sport were applied to predetermined unprotected sites of
701, SPF 701, Schering-Plough HealthCare the mid aspect of the back, as indicated in the FDA
Products Inc, Memphis, TN). sunscreen monograph.28 Within 22 to 24 hours after
irradiation, subjects returned to the testing laboratory
The formulations were applied to the subject’s for evaluation of UV-induced skin responses. A
back using a pipette and delivered in small droplets blinded trained evaluator graded the UV exposed
within pre-outlined skin sites; the droplets were sites for erythema using a warm fluorescent lamp
spread as quickly and uniformly as possible using a emitting 450 to 550 lux: the MED was the smallest UV
finger cot. For spray-on products, formulations were dose in the series to produce the first mild erythema
first sprayed into a beaker and swirled until no with clearly defined borders.
bubbles remained before being transferred to skin by Day 2eapplication of products and UV doses
pipette. for static SPF determination. Study A. On day
In study A, the 6 test products at the 4 application 2, two to four 50-cm2 rectangles were marked on the
densities were randomized among skin sites and subject’s back between the belt line and shoulder
subjects. Each subject received a standard sunscreen blades. The number of sites depended on the
(homosalate 8%)28 and up to 3 test products, applied expected SPF: only two high-SPF products could
at one of the 4 application densities (0.5, 1.0, 1.5, and be tested together at the higher dose levels, because
2.0 mg/cm2) so that each test product was evaluated of the long exposure times. A technician applied the
at all 4 amounts on at least 20 subjects. The 8% randomized density (0.5, 1.0, 1.5, or 2.0 mg/cm2) of
homosalate control was obtained commercially and one to three test products and the homosalate
had a labeled SPF of 4. standard sunscreen (2.0 mg/cm2) to the designated
In study B, the SPF determination of the 6 rectangles on the subject’s back. Test product allo-
sunscreen formulations applied at 0.5 and 1.0 mg/ cation was determined by randomization. After at
cm2 was conducted in 3 parallel panels of at least 20 least 15 minutes from application, 7 progressive UV
subjects each. Each subject received 4 test products/ doses were applied to determine the MED for
densities tested side by side to allow within-subject sunscreen-treated skin sites. Dose series were calcu-
comparisons of similar types of products (Table I); lated by multiplying the expected SPF of each
each panel received a fixed product/density combi- formulation, the initial subject’s unprotected MED,
nation: one panel compared the two sprays at both and the following number: 0.76, 0.87, 0.93, 1.00,
application densities; a second panel compared the 4 1.07, 1.15, and 1.32.28
lotions applied at 0.5 mg/cm2; and a third panel Expected SPF values were based on in vitro mea-
compared the 4 lotions applied at 1.0 mg/cm2. Test surements of each product at the 4 application
products and/or densities were randomized within densities: they were anticipated to be approximately
each panel. 75%, 50%, and 25% of the labeled SPF for application
densities of 1.5, 1, and 0.5 mg/cm2, respectively.
UV source Study B. On day 2, four 50-cm2 rectangles were
Single-port xenon arc solar simulators (model marked on the subject’s back between the belt line
16S, Solar Light Co, Glenside, PA) were used to and shoulder blades. A technician applied the ran-
administer UV doses. Output spectra of the light domized density (0.5 or 1.0 mg/cm2) of the 4 selected
J AM ACAD DERMATOL Ou-Yang et al 1223
VOLUME 67, NUMBER 6

Table I. Test product allocation

Test products
2
Panel 1 (20 subjects) (E) SPF 50 spray at 0.5 mg/cm (C) SPF 100 spray at 0.5 mg/cm2
(E) SPF 50 spray at 1.0 mg/cm2 (C) SPF 100 spray at 1.0 mg/cm2
Panel 2 (20 subjects) (A) SPF 30 lotion at 0.5 mg/cm2 (D) SPF 50 lotion at 0.5 mg/cm2
(F) SPF 70 lotion at 0.5 mg/cm2 (B) SPF 100 lotion at 0.5 mg/cm2
Panel 3 (20 subjects) (A) SPF 30 lotion at 1.0 mg/cm2 (D) SPF 50 lotion at 1.0 mg/cm2
(F) SPF 70 lotion at 1.0 mg/cm2 (B) SPF 100 lotion at 1.0 mg/cm2

SPF, Sunburn protection factor.

test products in their designated rectangles. The test group, between-sample comparisons were analyzed
products to be applied were determined by a ran- by a one-way analysis of variance. Panel 1 data were
domization code balanced by panel, application analyzed by a mixed linear model, with dependent
density, and site location, to the maximum extent variable SPF values, and random model term for
possible. At least 15 minutes after application, 7 dose (0.5, 1.0) and fixed term for sample (C, E), and
progressive UV doses were applied to determine the the interaction of dose and sample. Panel 2 (at dose =
MED for sunscreen-treated skin sites. Dose series 0.5) and panel 3 (at dose = 1.0) data analysis used a
were calculated as in study A. repeated measures analysis of variance to test for SPF
Expected SPF values were based on the in vitro differences among samples. Summary statistics for
measurements of each product at the two application these statistical analyses include the least-squares
densities (study A): they were anticipated to be mean difference between sample pairs and 95%
approximately 50% and 25% of the labeled SPF for confidence intervals, using Tukey-Kramer adjust-
application densities of 1.0 and 0.5 mg/cm2, ment for multiple comparisons. Statistical analysis
respectively. was conducted using SAS software (SAS Institute Inc,
Day 2erepeated MED determination. On day Cary, NC) Version 9.2 on an XP Pro platform.
2, 5 UV doses, progressively increasing by 25%
increments, were also readministered to an unpro- RESULTS
tected area of the mid aspect of the back. The 5-dose Study A
series was calculated based on multiples of the A total of 237 subjects completed the study and
original MED, as follows: 0.64, 0.80, 1.00 (original 233 were included in SPF calculations. Data for 4
MED), 1.25, and 1.56. subjects were excluded because of protocol
Day 3eevaluation of responses for SPF cal- violations.
culation and repeated MED. Skin responses Mean SPF values and statistical information for
were evaluated 22 to 24 hours after administration each test product and application density are pre-
of UV doses (day 3), using the 7-point erythema sented in Table II. For all 6 test sunscreens, the mean
grading scale. Grading was conducted by a trained SPF value was progressively lower with lower appli-
evaluator, who did not participate in product appli- cation densities. However, reduced application den-
cations or administration of UV doses. sities yielded proportionately higher mean SPF
values for products with higher labeled SPFs. SPF
SPF computation values for the 2.0-mg/cm2 application were slightly
After determination of the repeated MED as higher than labeled values. Measured SPF values
detailed above, SPF values were calculated for each were statistically different for sunscreens with differ-
subject as follows: Individual SPF = MED of pro- ent labeled SPF when tested at the same application
tected skin/repeated MED of unprotected skin. density and were statistically different for the same
Mean SPF values and statistical information for product when tested at different application densi-
each test product and application density were then ties. Correlation coefficients (R2) for linear curve fits
calculated.28 were all greater than 0.99, suggesting a linear corre-
lation between application densities of 0.5 to 2 mg/
Statistical analysis cm2 and SPF (Fig 1).
A one-way analysis of variance was performed
within samples to test for differences in SPF by dose, Study B
and orthogonal contrasts were constructed to test A total of 65 subjects completed the study and all
linearity of the dose response. Within each dose were included in SPF calculations. The results are
1224 Ou-Yang et al J AM ACAD DERMATOL
DECEMBER 2012

Table II. Study A: sunburn protection factor results

AeLabel SPF: 30 DeLabel SPF: 501 FeLabel SPF: 701 BeLabel SPF: 100 EeLabel SPF: 50 spray CeLabel SPF: 100 spray
2
2 mg/cm
Mean SPF 31.0 52.8 70.6 104.6 50.7 105.3
SD 4.2 6.4 8.7 8.1 5.0 11.1
n 20 21 20 20 20 20
95% CI 1.9 2.7 3.8 3.6 2.2 4.9
1.5 mg/cm2
Mean SPF 21.8 41.3 54.4 79.3 38.6 75.0
SD 2.4 4.2 5.0 7.4 4.3 8.0
n 20 20 20 20 20 20
95% CI 1.1 1.8 2.2 3.2 1.9 3.5
1 mg/cm2
Mean SPF 16.0 26.0 37.1 55.9 25.7 50.1
SD 1.3 2.5 4.5 5.0 2.8 5.2
n 20 20 20 20 20 20
95% CI 0.6 1.1 2.0 2.2 1.2 2.3
0.5 mg/cm2
Mean SPF 8.8 13.9 19.3 27.1 12.6 22.4
SD 1.1 1.5 1.4 1.6 1.5 3.1
n 20 20 20 20 20 20
95% CI 0.5 0.7 0.6 0.7 0.7 1.4

CI, Confidence interval; SPF, sunburn protection factor.

mg/cm2, the average SPF for labeled SPF 30 was 9.11,

for labeled 501 was 14.34, for labeled 701 was
19.27, and for labeled 100 was 27.85. In this
side-by-side test, the sunscreens with the higher
labeled SPF values consistently provided statistically
better protection than the sunscreens with the lower-
labeled SPF values at the application densities rele-
vant to consumers.

DISCUSSION
In recent years, advancements in sunscreen for-
mulations and access to photostabilized UV filter
technology have allowed companies to manufacture
products with SPF value up to 100. The marketing of
very higheSPF products (SPF [50) has spurred an
ongoing debate questioning their added clinical
benefits. Indeed, comparative investigations on
very higheSPF sunscreens are scant. Russak et al25
conducted a split-face, double-blind, randomized
Fig 1. Correlation for study A. Correlation coefficients study comparing an SPF 50 with an SPF 85 product. A
(R2) for linear curve fits were all greater than 0.99, total of 56 skier/snowboarders applied each sun-
suggesting linear relationship between application screen once to the assigned side of the face during a
amount and sunburn protection factor (SPF ) for all test sunny day at high altitude and subjects were exposed
products. to the sun during the snow activity for an average of
5 hours. The results showed that the product with
presented in Table III. The results confirmed the SPF 85 provided significantly more protection
linear relationship between amount of sunscreen against sunburn than the one with SPF 50.
applied and static SPF value for the high-SPF sun- Many studies have demonstrated that consumers
screens tested in study A, with the mean SPF value tend to use significantly less product than recom-
for 0.5-mg/cm2 applications resulting in approxi- mended (0.5-1.0 mg/cm2) and in uneven applica-
mately 25% of the labeled SPF. At applications of 0.5 tions,15-20 with a decrease in actual sunburn
J AM ACAD DERMATOL Ou-Yang et al 1225
VOLUME 67, NUMBER 6

Table III. Sunburn protection factor results for study B

AeLabel SPF: 30 DeLabel SPF: 501 BeLabel SPF: 100 FeLabel SPF: 701 CeLabel SPF: 100 spray EeLabel SPF: 50 spray
2
0.5 mg/cm
Mean SPF 9.11 14.34 27.85 19.27 25.82 13.28
SD 1.30 2.16 2.84 2.75 3.44 2.22
n 21 21 21 20* 22 22
95% CI 0.6 0.9 1.2 1.2 1.4 0.9
1 mg/cm2
Mean SPF 15.15 26.69 51.78 34.80 49.67 25.4
SD 1.63 3.55 5.08 4.82 7.45 3.6
n 21 21 20* 20* 20y 21
95% CI 0.7 1.5 2.2 2.1 3.3 1.6

CI, Confidence interval; SPF, sunburn protection factor.

*Test failure on one subject.
y
Test failure on two subjects.

protection.21-23 In fact, a study evaluating two sun- play a role in final film uniformity. In this regard, the
screens (SPF 15 and 30) at 4 applications densities authors selected formulations with very similar
(0.5, 1, 1.5, and 2 mg/cm2) on 40 volunteers, found emulsion bases (among lotions), so that comparison
that the actual SPF decreased from 27 to 7 (SPF 30 at 2 between products was more meaningful. In addi-
and 0.5 mg/cm2) and from 16 to 4 (SPF 15 at 2 and 0.5 tion, SPF testing at low application densities was also
mg/cm2), with a more linear trend than that sug- conducted in a side-by-side manner to confirm the
gested by the Beer-Lambert law.22 Another study, validity of the differences between formulations with
testing two sunscreens (SPF 30 and 35) at the same 4 differently labeled SPF.
application densities on 15 Asian volunteers, found a The current study did not find an increase of
similar decrease in sun protection.21 Bimczok et al,23 variation as observed by Bimczok et al23 when the
using products with SPF between 20 and 25 and 3 application density was moved from 2 to 0.5 mg/cm2
application densities (0.5, 1, and 2 mg/cm2), showed in this single-center test. However, the authors are in
a linear correlation between application density and agreement with the FDA and Bimczok et al23 in
SPF value, with reduced amounts of sunscreens continuing to support the application density of 2.0
producing a decrease in their actual SPF. In the mg/cm2 as a standard for laboratory SPF testing to
current study, using much higher SPF values, there maintain reproducibility across laboratories. SPF
was also a linear relationship between application values should be considered to be a relative indicator
densities (from 0.5-2 mg/cm2) and labeled SPF (from of protection when comparing two different pro-
30-100), with the mean actual SPF of the 0.5-mg/cm2 ducts, and not as absolute values that guarantee
dose being approximately 25% of the labeled SPF for sunburn-free protection based on individual sun-
all 6 test products. Herzog29 also concluded, using burn ‘‘burn’’ time and the current sun UV intensity.31
in-silico methods, that sunscreen products with UVA/ Consumers have learned to choose appropriate SPF
UVB absorbance ratios between 0.4 and 0.8, such as levels that work for them under their usual sun-
the ones used in the current study, show a linear exposure habits, and complaint rates for sunscreen
relationship between application density and SPF. It failure to protect are in fact low.
is not surprising that sunscreen protection on human The results of this study are particularly important
skin may not obey an exponential Beer-Lambert in view of the 2007 FDA proposed amendment to the
relationship, because the irregular surface of the skin 1999 sunscreen final monograph13 and of the latest
can lead to uneven film distribution within the FDA proposed rule on over-the-counter sunscreens
testing site.30 released in June 2011,24 both advocating a maximum
It should be noted that during actual consumer SPF label of ‘‘501.’’ According to the 2011 proposed
use, high-SPF formulations (with lower water con- rule, the FDA continues to question whether there is
tent) may have different spreadability when com- any additional clinical benefit in using sunscreens
pared with lower SPF products (with higher water with SPF above 50 and is thus proposing to limit the
content), and, therefore, laboratory results conduct- maximum labeled SPF to ‘‘501’’ until further clinical
ed under standard application conditions may be proof is submitted. The authors believe that this
somewhat different from actual in-use SPF. Emulsion study supports a more appropriate level of clinical
type and other ingredients in the emulsion may also protection obtained from sunscreens of labeled SPF
1226 Ou-Yang et al J AM ACAD DERMATOL
DECEMBER 2012

values above 50 when used at doses more consistent 8. American Academy of Dermatology. Melanoma. Available
with consumer behavior. In fact, sunscreens with SPF from: http://www.aad.org/media-resources/stats-and-facts/
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SPF 19 in this study even at concentrations as low as violet photocarcinogenesis. J Am Acad Dermatol 1980;3:30-5.
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below SPF 50 may not produce enough protection at 12. Green AC, Williams GM, Logan V, Strutton GM. Reduced
the same dose (actual SPF 13-14 in this study). It is melanoma after regular sunscreen use: randomized trial
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13. Sunscreen drug products for over-the-counter human use.
actual mean SPFs 15.15 and 9.11 when applied, proposed amendment of final monograph proposed rule for
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of Pagnoni Consulting LLC, for her writing and editorial 2004;50:P31.
assistance in the preparation of this manuscript. Dr 18. Lademann J, Schanzer S, Richter H, Pelchrzim RV, Zastrow L,
Pagnoni is a consultant for Johnson and Johnson Golz K, et al. Sunscreen application at the beach. J Cosmet
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20. Reich A, Harupa M, Bury M, Chrzaszcz J, Starczewska A.
Van Buskirk is a consultant for Johnson and Johnson
Application of sunscreen preparations: a need to change the
Consumer Companies.
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