Retrospective Review of Dermal Safety Studies of Organic Sunscreens.

BACKGROUND

Sunscreens can reduce skin cancer and sunburn. Recent studies on dermal penetration have raised concerns about the safety of sunscreens with organic ultraviolet (UV) filters.

OBJECTIVE

The aim of the retrospective study was to assess the dermal safety of chemical sunscreens containing the chemical filters avobenzone, octocrylene, homosalate, and octisalate.

METHOD: A retrospective assessment was conducted of clinical results on sunscreen products of human repeat irritation patch test, cumulative irritation, photo allergy, and photo toxicity.

RESULTS

An analysis of human repeat irritation patch test results involving 38,950 subjects demonstrated that 99.5% of participants experienced no sensitization. Seven participants exhibited a reaction, which was attributed to the preservative rather than the UV filters. Cumulative irritation results in 4,715 subjects showed that 97.8% of participants had no visible irritation, and 29 subjects showed the lowest irritation grade, representing a barely perceivable erythema. No photo-allergy or photo-toxicity reactions were observed.

CONCLUSION

The findings show no to minimal risks of dermal irritation, sensitization, photo-allergy, and photo-irritation, reinforcing the safety profile of these sunscreens. This evidence is valuable in reassuring the public about the strong safety record of organic sunscreens.