High SPF sunscreen provides significant clinical benefit in actual use conditions: SPF 100+ is more effective than SPF 50+

        In the 2011 proposed monograph, the US Food and Drug Administration requested additional data stating “there is currently insufficient evidence that there is clinical benefit to the consumer at SPF above 50.” In real-world settings, consumers apply sunscreens at densities lower than are used to clinically determine SPF and the linear dependence of SPF to application density is well established. It is hypothesized that a sunscreen with a higher SPF would provide greater in-use efficacy compared with one currently labeled at the proposed maximum of SPF 50+. The objective this study was to evaluate the difference in sunburn protection provided by different SPF sunscreens during a day of downhill snow skiing. Healthy men and women ≥18 years of age participated in a one day split face, randomized, double blind study in Vail, Colorado. The difference in sunburn protection provided by two currently available sunscreens (SPF 50+ and SPF 100+) was evaluated. Products were supplied in a kit containing two overwrapped tubes of sunscreen marked “right” and “left.” Each subject wore both sunscreens simultaneously, with product application randomized to either the right or left side of the face. Subjects were to use the sunscreens as they would normally during ski activities. Diaries were used to record sun exposure time and the frequency and timing of sunscreen reapplications. Subjects reported the next morning for clinical evaluation. The primary endpoint was a bilateral sunburn comparison between treatment areas (left and right sides of the face). The secondary endpoint was the erythema score of each side of the face, graded using a 5-point scale. A total of 199 subjects (42% women, 37 ± 16 years old) were enrolled. After sun exposure, 55.3% of subjects were more sunburned on the SPF 50+ side than the SPF 100+ side, whereas only 5% of subjects were more sunburned on the SPF 100+ side (P < .001). Clinical grading showed 2× more increase in erythema on the SPF 50+ side compared with the SPF 100+ side. No differences were observed between the SPF 50+ or SPF 100+ sides in the amount ( ± SD) of sunscreen used (1.15 ± 1.76 g SPF 50+ vs 1.09 ± 1.62 g SPF 100+) or in the frequency of sunscreen reapplications (1.1 ± 1.0 SPF 50+ vs 1.1 ± 1.0 SPF 100+). The average duration of sun exposure for all subjects was 6.05 ± 1.29 hours. In conclusion, SPF 100+ sunscreen demonstrated a clear clinical benefit over SPF 50+ sunscreen in the prevention of sunburn under actual usage conditions.
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