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Original Article

SPF 100+ sunscreen is more protective against sunburn than SPF 50+ in actual- use:
Results of a randomized, double-blind, split-face, natural sunlight exposure, clinical trial

Authors:
Joshua D. Williams, PhD1; Prithwiraj Maitra, PhD1; Evren Atillasoy, MD1; Mei-Miau Wu, DrPH1;
Aaron S. Farberg, MD2; Darrell S. Rigel, MD3

[1] Johnson & Johnson Consumer Inc., Skillman, NJ

[2] Icahn School of Medicine at Mount Sinai, New York, NY
[3] New York University School of Medicine, New York, NY

Funding Sources/Conflicts of Interest:

This study was fully funded by Johnson & Johnson Consumer Inc. Drs Williams, Atillasoy, Maitra,
and Wu are employees of Johnson & Johnson Consumer Inc. As sponsor employees and authors,
they were involved in the design, management, data analysis, data interpretation, preparation,
review and approval of the manuscript as well as in the decision to submit for publication. Dr.
Farberg serves as a consultant for Johnson & Johnson Consumer Inc. Dr. Rigel serves as a
consultant for Johnson & Johnson Consumer Inc., Beiersdorf, and Proctor & Gamble.

IRB Status:
The study protocol was approved by IntegReview IRB (Austin, Texas), and all participants gave
written informed consent before enrollment (ClinicalTrials.gov: NCT02952235).

Previous Presentation:
The data were presented in part at the American Academy of Dermatology 2017 Annual Meeting.
This article has not been published and is not under review by any other journal or publication.

Corresponding Author/Reprint Requests:

Darrell S. Rigel, MD, MS
Ronald O. Perelman Department of Dermatology
New York University School of Medicine
35 E 35th St, Suite 208, New York, NY 10016
Email: darrell.rigel@gmail.com
Phone: 212-684-4542
Fax: 212-689-5748ACCEPTED MANUSCRIPT

Word count:
Abstract: 200
Capsule Summary: 58
Manuscript: 2441
References: 28
Figures: 6
Tables: 0

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SPF 100+ sunscreen is more protective against sunburn than SPF 50+ in actual-use: Results
of a randomized, double-blind, split-face, natural sunlight exposure clinical trial

Abstract
Background: The value of additional photoprotection provided by use of high SPF sunscreens is
controversial and limited clinical evidence exists.
Objective: To compare the sunburn protection provided by SPF100+ and SPF50+ sunscreen in
conditions of actual use.
Methods: 199 healthy men and women (≥18 years) participated in a natural sunlight, single
exposure, split face, randomized, double blind study in Vail, Colorado. Each participant wore both
sunscreens simultaneously during activities with no usage restrictions other than treatment area
designation. Erythema was clinically assessed the day following exposure. Comparative efficacy was
evaluated through bilateral comparison of sunburn between treatment areas and erythema score as
evaluated separately for each treatment area.
Results: Following an average 6.1 ± 1.3 hours of sun exposure, investigator blinded evaluation
identified 55.3% (110/199) of the participants as more sunburned on the SPF50+ and 5% (10/199)
on the SPF100+ protected side. Post exposure, 40.7% (81/199) of the participants exhibited
increased erythema scores ≥ 1 on the SPF50+ protected side as compared to 13.6% (27/199) on the
SPF100+.
Limitations: Single day exposure may not extrapolate to benefits of longer-term protection.
Conclusion: SPF100+ sunscreen was significantly more effective in protecting against sunburn
than SPF50+ sunscreen in actual-use conditions.
Trial Registration: ClinicalTrials.gov(NCT02952235).

Capsule Summary
- High SPF sunscreens are suggested to provide greater photoprotection under conditions of actual
use by compensating for typical sunscreen usage behavior.
- In this natural sunlight, randomized, double-blind evaluation, SPF100+ sunscreen was
significantly more protective against sunburn than SPF50+.
- Sunscreens with labeled SPF values above 50+ may provide options for better sunburn protection
in real-world conditions.

Key Words (6-10)

Sunscreen, sunburn, sun protection factor, high SPF, actual use, outdoor recreation, natural
sunlight,photoprotection

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Introduction:
The sun protection factor (SPF) of a sunscreen communicates the efficacy of a product for
protection against the erythema-inducing ultraviolet (UV) radiation that causes sunburn. Use of
high SPF sunscreen provides enhanced protection against sunburn and UV-induced skin cell
damage, and this protection has been suggested to be particularly beneficial under conditions of
actual use by compensating for application densities lower than those utilized in standardized
methods for product SPF testing.1 In a recent survey, more than 80% of dermatologists
indicated belief that using a high SPF sunscreen provided an additional margin of safety.2 The
value of the additional protection provided by certain high SPF sunscreens remains the subject
of ongoing debate.. This debate is exemplified by the widespread dissemination of two conflicting
messages: one correctly indicating that the SPF of a sunscreen increases proportionally to the
amount erythema-inducing UV radiation that is prevented from reaching the user’s skin, and
another incorrectly indicating that sunscreens with SPFs greater than 30 offer only minor
improvements in protection based on the absolute percentage increase of erythema-inducing
radiation blocked.3 However, limited clinical evidence exists to support that high SPF values as
determined by standardized laboratory testing translate to enhanced sunburn protection in the
environments and conditions where sunscreens are utilized.

To the authors’ knowledge, there is only one study which has attempted to directly compare high
and very high SPF sunscreens for sunburn protection in actual use. Russak et al. demonstrated
that an SPF85 sunscreen was more effective than an SPF50 in preventing sunburn under
conditions of high-altitude skiing.4 This study was discussed by the US Food and Drug
Administration in the 2011 proposed sunscreen monograph revision in which the generalizability
of the findings were questioned, primarily in that participants were instructed not to reapply the
test products in an attempt to minimize the potential for study behavior bias, which is contrary to
required sunscreen label usage directions.5 Consistent educational messaging and consumer
confidence in sun-safe behaviors, including the appropriate use of sunscreens, are key
components in achieving the current national priority of skin cancer prevention. 6 To explore the
validity of the previous findings and provide further clinical evidence, the current study was
designed to repeat the essential elements of the previous study and address the criticisms,
enabling a critical test of the hypothesis that SPF100+ sunscreen will provide greater effective
sunburn protection compared with SPF50+ sunscreen under actual use conditions.

Methods:
This study was a single-center, randomized, split-face, double-blinded study conducted on a
sunny day (March 21, 2016) during normal recreational skiing/snowboarding in Vail, Colorado.
The study protocol was approved by IntegReview IRB (Austin, Texas), and all participants gave
written informed consent including photo release before enrollment (ClinicalTrials.gov:
NCT02952235).
CRI
Study Population
Healthy men and women, Fitzpatrick skin types I–III, at least 18 years-of-age and planning to
participate in outdoor ski activities were eligible. Medical history and demographic information
was collected through interview. Exclusion criteria included existing skin disease, concurrent use
of sun sensitizing medications (e.g. tetracyclines, antifungals, certain diuretics), known allergies
to topical skincare products (including sunscreens), or preexisting sunburn (baseline erythema
score > 0.5).

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Treatment
The sunscreens investigated in the study were: NEUTROGENA® Ultra Sheer® Dry-Touch
Sunscreen, broad spectrum SPF100+ (Johnson & Johnson Consumer Inc.; containing
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10%, oxybenzone 6%), and
Banana Boat® Sport Performance®, broad-spectrum SPF50+ (Edgewell Personal Care Brands,
LLC; containing avobenzone 3%, homosalate 10%, octocrylene 6%). Enrolled subjects were
randomized to one of two treatment groups defined by test product application side. Preweighed
sunscreen tubes were provided to the subjects in a kit containing both test products in
overwrapped tubes marked “right” and “left” and a sun exposure diary to record time spent
outdoors. Investigators and subjects were blinded to treatment assignment, and study personnel
involved in test product dispensing or supervision of initial product application did not participate
in subject examination. Each test product carried the full sunscreen Drug Facts Label excluding
the ingredient lists, which permitted subjects full visibility to the ‘Uses’, ‘Warnings’, and
‘Directions’ (application/reapplication) sections as if the products had been purchased retail.
Thorough removal of all facial products was confirmed for all participants prior to study entry and
baseline evaluation. Upon receipt of test kit, participants were instructed to apply the sunscreens
to the designated sides of the face and neck as they normally would when partaking in outdoor
activities and to use provided wipes to thoroughly clean hands between right- and left-side
applications to avoid cross-contamination. Each participant carried the test kit for the duration of
their activities permitting for unrestricted sunscreen reapplication. All participants were assessed
for erythema by a single board-certified dermatologist the morning following the exposure period.
Each participant reported product reapplication frequency and the returned products were
weighed to determine amounts dispensed. Product dosage (product dispensed in mg per
application area in cm2), was derived utilizing a simplified body surface area calculation7 with
application area estimated at 2.75% for one side of the face and neck. 8,9 Average application
area was estimated at 548.3 cm2 for male and 473.9 cm2 for female participants. The primary
efficacy endpoint was a bilateral comparison of sunburn between treatment areas (left and right
sides). The scoring utilized a condensed two-side difference scale: L1 = subject’s left side
noticeably more sunburned than right side; 0 = no difference in sunburn; R1 = subject’s right side
noticeably more sunburned than left side.

The secondary endpoint was erythema score determined for each treatment area using a 5- oint
scale, including half-point grades: 0 = no burn, 1 = possible burn, 2 = defined redness, 3 =
severe sunburn, and 4 = edema and blisters.10 All sun exposure occurred during the same single
day period. Ambient UVA and UVB levels were measured (ILT72CE UVA and ILT73CE UVB
Radiometers, International Light Technologies, Inc., Peabody, Massachusetts) to document the
amount and quality of exposure. Per-subject UV exposure doses were calculated by pairing
subject exposure diary and the radiometry data.

Data Analysis
The primary efficacy variable was analyzed in intent-to-treat subjects using the Fisher’s exact
test on the side-by-side score between treatment randomization groups. The 0-outcomes (no
difference) were excluded from the analysis. Demonstration of treatment effect required a
significant association (P < .05) between side of face and group. To determine the impact of skin
type and sunscreen reapplication, post hoc analyses of the primary efficacy variable were
conducted by Fitzpatrick skin type11 and reported reapplication frequency. For the secondary

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endpoint, treatment difference was evaluated by comparing the two treatment randomization
groups with respect to the difference in erythema score between the left and right sides of the
face using the exact Wilcoxon rank sum test.

A sample size of 176 subjects was prospectively estimated to provide at least 90% power to
detect an overall difference between the tested sunscreen products, based on side-by-side
comparison of erythema and utilizing a two-sided test at the significance level. This assumed
7.5% of the population would experience more sunburn on the SPF50+ side and 0.5% on the
SPF100+ side, as estimated from the previous study.4

Results:

Participants

A total of 199 participants were randomized to treatment, 99 to Group 1 (Left SPF50+ / Right
SPF100+) and 100 to Group 2 (Left SPF100+ / Right SPF50+) (Figure1). The study population
consisted of 57.8% men (115/199) and 42.2% women (84/199), average age of 37.4 ± 16.3
years.

Efficacy

During blinded evaluation conducted the day following the exposure period, the SPF50+
protected side of the face was assessed as more sunburned than the SPF100+ protected side of
the face in 55.3% (110/199) of the participants, with 5.0% (10/199) evaluated to exhibit the
contrary (P < .001) (Figure 2A). The percentage of subjects evaluated to be more sunburned on
the left and right sides of the face was observed to be similar in magnitude yet opposite in
distribution between the two randomization groups, indicating a minimal impact of evaluation or
exposure side bias (Figures 2B). Sunburn severity, as indicated by the mean increase in post-
exposure erythema score, was lower on the SPF100+ protected side as compared to the
SPF50+ protected side of the face, 0.14 ± 0.31 vs 0.330 ± 0.44 (P < .001) (Figure 3A). The
highest post-exposure erythema scores were observed on the SPF50+ protected side in both
treatment randomization groups (Figure 3B). Overall, 40.7% (81/199) of the participants
exhibited a post-exposure erythema score ≥ 1 on the SPF50+ protected as compared to 13.6%
(27/199) on the SPF100+ protected side. No significant differences were observed in the
average amount dispensed or number of reapplications reported between the SPF50+ and
SPF100+ test products. An average of 1.15 ± 1.76 g of the SPF50+ and 1.09 ± 1.62 g of the
SPF100+ test product was dispensed, corresponding to application densities of 1.1 ± 1.3 and 1.0
± 0.98 mg/cm2, respectively. The average number of reapplications reported over the exposure
period was 1.1 for both test products.

The distribution with which the SPF50+ or SPF100+ protected side of the face was evaluated to
be more sunburned was not observed to change with more frequent product reapplication
(Figure 4A). Additionally, the distribution with which the SPF50+ or SPF100+ protected side of
the face was evaluated to be more sunburned was similar for each of the included Fitzpatrick
skin type groups (Figure 4B). A significant association between side of face and group was

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determined in each of the skin type groups evaluated (Type I (P = .002), Type II (P < .001), Type
III (P = .033)), indicating a protective treatment effect for the SPF100+ product.

The average exposure duration was 6.1 ± 1.3 hours. Solar radiometer readings over time are
shown in Figure 5. Average cumulative unweighted UVA (320-400 nm) and UVB (290-320 nm)
exposure doses over the study period were determined to be 54.9 ± 11.8 and 1.0 ± 0.22 J/cm2,
respectively. This equates to an estimated cumulative exposure of 13-25 minimal erythemal
doses, based on erythemal sensitivities to full. UVB reported to range between 40-76 mJ/cm2 for
Fitzpatrick type II skin.11-13 Both test products were well tolerated with no adverse events
reported.

Discussion:

Downhill skiing and snowboarding are outdoor recreational activities enjoyed by millions in the
U.S. each year, where the conditions predispose participants to increased sun exposure and
subsequently an increased risk of sunburn. High-altitude alpine ski conditions afford a unique
and appropriate environment to evaluate the clinical benefits of sunscreens. While UV levels at
elevated ski altitudes are high, they are not extreme. Levels of erythema-inducing UV radiation
have been shown to be similar between the elevated altitudes of Vail, Colorado and sea level in
Orlando, Florida during same time of year.14,15 Additionally, the UV exposure conditions during
mid-summer at lower latitude ocean beaches are far more intense than those observed even
toward the end of the late spring ski season.16-21

While not extreme in terms of UV index, the high albedo of the snow covered surfaces mean that
vertically oriented body surfaces like the face receive a greater amount of UV exposure in
contrast to a beach setting where the highest impact of erythema-inducing UV occurs on body
surfaces oriented horizontally to the ground.22 The observed sunburn was consistent with this
alpine exposure pattern and generally presented as diffuse erythema over a large portion of the
exposed face, (representative images, Supplementary Figure 1). It is worth noting that in the
recreational ski setting, sun exposure behaviors are incidental to the recreational activity, in that
the duration of sun exposure is primarily dictated by the ski area’s hours of operation and not a
desire to tan.23 The results of the current study demonstrate that the SPF100+ sunscreen
provided a level of enhanced sunburn protection that was clearly observable following a single
period of exposure. Erythema severity was diminished on the SPF100+ protected side, as
demonstrated by both a reduced number of subjects exhibiting a shift from baseline as well as a
significant decrease in post-exposure erythema score. The mean change in erythema score from
baseline on the SPF50+ side of the face was observed to be slightly more than twice that of the
SPF100+ side, 0.33 ± 0..44 vs 0.14 ± 0.31, which is consistent with the fact that a sunscreen
with double the SPF will allow approximately half of the erythema-inducing photons to reach the
skin if the two products are utilized similarly. Participants applied both test products at
approximately half the 2 mg/cm2 density utilized for standardized SPF testing, and over 70% of
participants reported one or fewer reapplications over the six-hour exposure period. This
confirms results from previous studies indicating that sunscreens are not utilized in a manner
that allows for realization of the laboratory-determined, labeled SPF.1,24,25 Participants utilized
the test products similarly in terms of both amount dispensed and frequency of product
reapplication. This indicates that the differences observed between the test products were a
result of product efficacy rather than application preference and provides data contrary to the

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suggestion that higher SPF products will be used less due to thicker or less-desirable aesthetics.
Increased reapplication frequency did not mitigate the efficacy differences between the test
products, indicating that sunscreen reapplication may play a primary role in maintenance rather
than enhancement of a sunscreen’s protection efficacy.

Conclusions:

This study evaluated the comparative efficacy of two marketed sunscreens utilizing approved
concentrations and combinations of U.S. OTC active UV filter ingredients. No other safety
endpoints were evaluated and both products were well tolerated. As participants were blinded to
the SPF values of the test products, the potential psychological impact of label SPF on sun
exposure and sunscreen usage behaviors was not evaluated. If the sunscreen usage patterns in
the current study are held constant, the efficacy differences observed between the two test
products are likely reproducible in any environment where UV exposure is similar or greater.
Sunburn protection was evaluated following a single day of exposure which may not extrapolate
to the extended skin health benefits associated with longer-term photoprotection.

However, the long-term, appropriate use of sunscreen as a component of photoprotection has

been estimated to reduce the incidence of skin cancer by approximately 50–75%.26-28 The results
of the current investigation are consistent with previous investigations in demonstrating that
higher SPF sunscreen products (greater than SPF50+) have utility in providing meaningfully
enhanced sunburn protection during actual use.4 In this natural sunlight evaluation, SPF100+
sunscreen was significantly more effective in protecting against sunburn than SPF50+
sunscreen, with a protective treatment effect determined for all evaluated skin types. These
findings suggest that sunscreens with labelled SPFs greater than 50+ may provide users with
options for better sunburn protection in certain settings which has important implications for
photoprotection recommendations as a component of skin cancer prevention.TED MANUSCRIPT

Acknowledgments

Medical writing and editorial support was provided by Alex Loeb, PhD, CMPP, of Evidence
Scientific Solutions (Philadelphia, Pennsylvania) and was funded by Johnson & Johnson
Consumer Inc. We also thank Karen Nern, MD for her help with the study.

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References:

1.Ou-Yang H, Stanfield J, Cole C, Appa Y, Rigel D. High-SPF sunscreens (SPF>/=70) may

provide ultraviolet protection above minimal recommended levels by adequately
compensating for lower sunscreen user application amounts. J Am Acad Dermatol.
2012;67(6):1220-1227

2.Farberg AS, Glazer AM, Rigel AC, White R, Rigel DS. Dermatologists' Perceptions,
Recommendations, and Use of Sunscreen. JAMA Dermatol. Jan 01 2017;153(1):99-101.

3.Herzog SM, Lim HW, Williams MS, de Maddalena ID, Osterwalder U, Surber C. Sun
Protection Factor Communication of Sunscreen EffectivenessA Web-Based Study of
Perception of Effectiveness by Dermatologists. JAMA Dermatol. 2017;153(3):348-350

4.Russak JE, Chen T, Appa Y, Rigel DS. A comparison of sunburn protection of high-sun
protection factor (SPF) sunscreens: SPF 85 sunscreen is significantly more protective than
SPF50. J Am Acad Dermatol. 2010;62(2):348-349.

5.Food and Drug Administration. Revised Effectiveness Determination; Sunscreen Drug

Products for Over-the-Counter Human Use. 2011; 76 FR 35672 at 35674-35675.

6.U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to
Prevent Skin Cancer. Washington, DC: U.S. Dept of Health and Human Services, Office of
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7.Mosteller RD. Simplified calculation of body-surface area. N Engl J Med.

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10.Ou-Yang H, Jiang LI, Meyer K, Wang SQ, Farberg AS, Rigel DS. Sun Protection by
Beach Umbrella vs Sunscreen With a High Sun Protection Factor A Randomized Clinical
Trial. JAMA Dermatol. 2017;153(3):304–308.

11.Fitzpatric TB. The validity and practicality of sun-reactive skin types I through VI. Arch
Dermatol. 1988; 124:869-871

12.Van Weelden H, Baart De La Falille H, Young E, Van Der Leun JC. A new development in
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14.Rigel DS, Rigel EG, Rigel AC. Effects of altitude and latitude on ambient UVB radiation. J
Am Acad Dermatol. 1999;40(1):114-116.

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 15.NOAA Center for Weather and Climate Prediction. UV index: Annual time series.
http://www.cpc.ncep.noaa.gov/products/stratosphere/uv_index/uv_annual.shtml. Accessed
May 30, 2017.

16.Rigel EG, Lebwohl MG, Rigel AC, Rigel DS. Ultraviolet radiation in alpine skiing:
magnitude of exposure and importance of regular protection. Arch Dermatol.
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17.O'Riordan DL, Steffen AD, Lunde KB, Gies P. A day at the beach while on tropical
vacation: sun protection practices in a high-risk setting for UV radiation exposure. Arch
Dermatol. 2008;144(11):1449-1455.

18.Grifoni D, Carreras G, Sabatini F, Zipoli G. UV hazard on a summer's day under

Mediterranean conditions, and the protective role of a beach umbrella. Int J Biometeorol.
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19.Kimlin MG, Wong JC, Parisi AV. Simultaneous comparison of the personal UV exposure
of two human groups at different altitudes. Health Phys. 1998;74(4):429-434.

20.Ambach W, Blumthaler M, Schopf T. Increase of biologically effective ultraviolet radiation

with altitude. J Wilderness Med. 1993;4:189-197.

21.Blumthaler M, Webb AR, Seckmeyer G, Bais AF, Humber M, Mayer B. Simultaneous

spectroradiometry: A study of solar UV irradiance at two altitudes. Geophysical Res Lett.
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23.Buller DB, Andersen PA, Walkosz BJ, et al. Compliance with sunscreen advice in a
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Dermatol. 2012;66(1):63-70.

24.Grosick T, Tanner PR. Efficacy as used, not as tested, is true measure of sunscreen
performance (P121). J Am Acad Dermatol. 2004;50(3):P31.

25.Autier P, Boniol M, Severi G, Doré JF, European Organization for Research and
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27.Olsen CM, Wilson LF, Green AC, et al. Cancers in Australia attributable to exposure to
solar ultraviolet radiation and prevented by regular sunscreen use. Aust N Z J Public Health.
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sunscreen use: randomized trial follow-up. J Clin Oncol. 2011;29(3):257-263.

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Figure Legends

Figure 1. Diagram of Patient Flow Through the Study

Figure 2. Bilateral sunburn comparison between sides of the face receiving different
treatments. Panel A, overall distribution of comparison scores in intent-to-treat population
indicating significant number of more sunburned evaluations occurring on the SPF 50+
protected side, with treatment effect indicated by significant association between side of face
and group (P < .001). Panel B, distribution of comparison scores observed for the two
randomization groups (Group 1 (Left SPF50+ / Right SPF100+) and Group 2 (Left SPF100+
/ Right SPF50+)).

Figure 3. Erythema score comparison between different treatments. Panel A, change in

mean erythema score from baseline in intent-to-treat population indicating a greater increase
in erythema score on the SPF 50+ protected side, with treatment effect indicated by
significant difference in the left vs right side erythema score between randomization groups
(P < .001). Panel B, distribution of erythema scores observed before and after sun exposure
period for the two randomization groups (Group 1 (Left SPF50+ / Right SPF100+) and
Group 2 (Left SPF100+ / Right SPF50+)). Standard error of the mean (SEM) = standard
deviation/√n.

Figure 4. Subgroup analysis of bilateral sunburn comparison between sides of the face
receiving different treatments. Panel A, overall distribution of comparison scores by reported
number of test product reapplications. Panel B, overall distribution of comparison scores by
Fitzpatrick Skin Type.

Figure 5. Solar radiometer measurements taken over the course of the exposure period from
fixed position at the base elevation of the ski slopes. Shading indicates timing of observed thin
cloud cover which would slightly diminish the UV exposure of participants outdoors during these
periods as compared to clear sky conditions.

Supplementary Figure 1. Post exposure subject images. Panel A, examples of subjects

exhibiting bilateral discrepancy in erythema scores. Panel B, examples of subjects exhibiting
bilateral equivalency both when observed to be adequately and inadequately photoprotected.
Panel C, examples subjects presenting at each of the observed erythema severity scores,
highest score was a 2.5.ACCEPTED MANUSCRIPT

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Figures

Figure 1

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Figure 2

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Figure 3

1. 447

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Figure 4

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Figure 5

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Supplementary Figure 1

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Supplemental

Table 1, baseline demographic and clinical characteristics

2.

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