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

https://doi.org/10.1016/j.jaad.2017.12.062Get rights and content

Background

The value of additional photoprotection provided by use of high–sun protection factor (SPF) sunscreens is controversial, and limited clinical evidence exists.

Objective

To compare the sunburn protection provided by SPF 100+ and SPF 50+ sunscreen in conditions of actual use.

Methods

A total of 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 use restrictions other than designation of the treatment area. Erythema was clinically assessed on 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% of the participants (110 of 199) as more sunburned on the SPF 50+ protected side and 5% (10 of 199) on the SPF 100+ protected side. After exposure, 40.7% of the participants (81 of 199) exhibited increased erythema scores (by ≥1) on the SPF 50+ protected side as compared with 13.6% (27 of 199) on the SPF 100+ protected side.

Limitations

Single-day exposure may not extrapolate to benefits of longer-term protection.

Conclusion

SPF 100+ sunscreen was significantly more effective in protecting against sunburn than SPF 50+ sunscreen in actual use conditions.

Section snippets

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 the instituional review board IntegReview (Austin, TX), and all participants gave written informed consent, including a photo release, before enrollment (ClinicalTrials.gov identifier, NCT02952235).

Participants

A total of 199 participants were randomized to treatment: 99 to group 1 (left SPF 50+/right SPF 100+) and 100 to group 2 (left SPF 100+/right SPF 50+) (Fig 1). The study population consisted of 57.8% men (115 of 199) and 42.2% women (84 of 199), with an average age of 37.4 ± 16.3 years. Demographic and baseline characteristics for all randomized subjects may be found in Supplemental Table I (available at http://www.jaad.org).

Efficacy

During blinded evaluation conducted on the day following the exposure

Conclusions

This study evaluated the comparative efficacy of two marketed sunscreens that each utilize approved concentrations and combinations of US over-the-counter active UV filter ingredients. No other safety end points were evaluated and both products were well tolerated. As participants were blinded to the SPF values of the test products, the potential psychologic impact of label SPF on sun exposure and sunscreen use behaviors was not evaluated. If the sunscreen use patterns in the current study are

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    Funding sources: Supported 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 article, as well as in the decision to submit it 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.

    Presented in part at the 75th Annual Meeting of the American Academy of Dermatology, Orlando, FL; March 3-7, 2017.

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