Error: 429: HTTP/2 429 Error: 429: HTTP/2 429 Retrospective Review of Dermal Safety Studies of Organic Sunscreens - JDDonline - Journal of Drugs in Dermatology

Retrospective Review of Dermal Safety Studies of Organic Sunscreens

September 2025 | Volume 24 | Issue 9 | 9191 | Copyright © September 2025


Published online August 21, 2025

doi:10.36849/JDD.9191

Leigh T. Wilson MSa, Christopher Chu PhDa, Steven Q. Wang MDb, Regine Amponin MDa, Joshua D. Williams PhDc, Michael D. Southall PhDa, Sadaff Ejaz PhDa

aKenvue Medical and Clinical Safety Sciences, Summit, NJ
bHoag Memorial Hospital Presbyterian, Newport Beach, CA
cKenvue Translational Sciences, Summit, NJ

Abstract
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.

J Drugs Dermatol. 2025;24(9): doi:10.36849/JDD.9191

INTRODUCTION

Ultraviolet (UV) radiation from sunlight contributes to skin damage, premature aging, and the development of skin cancer.1,2 UV rays, both UVA and UVB, penetrate the skin and cause both direct and indirect damage to skin cells. UVB (280-320 nm) affects mostly the epidermis and is the primary cause of erythema.3 UVA (320-400 nm), instead, penetrates deeper into the dermis and is the main culprit in photoaging.4 The damage from UV radiation leads to mutations that can disrupt normal cell growth and repair processes, increasing the risk of skin cancers.5 Prolonged exposure to UV radiation also accelerates the breakdown of collagen and elastin,6,7 leading to premature skin aging, sunburns, and weakened immune responses.

When used properly, sunscreen is effective in preventing sunburn, skin cancer, and premature photoaging. Sunscreens are generally categorized into 2 types: physical and organic, based on the composition of their UV filters. Physical sunscreens contain UV filters such as zinc oxide and/or titanium dioxide, while organic sunscreens are formulated with chemical UV filters. Some of the most commonly used chemical UV filters include avobenzone, octocrylene, homosalate, and octisalate. Contrary to popular belief, both physical and chemical filters function by absorbing, reflecting, and scattering UV radiation.8

In 2019 and 2020, studies conducted by the US Food and Drug Administration (FDA) revealed systemic absorption of chemical UV filters when sunscreen was applied at the maximal usage levels.9,10 These findings led the FDA to request further safety data on sunscreens containing chemical UV filters.

While this data is still being gathered, we conducted a retrospective analysis of approximately 39,000 subjects who participated in clinical safety studies examining sunscreens formulated with the 4 most commonly used chemical UV filters: avobenzone, octocrylene, homosalate, and octisalate. The results of this analysis provide valuable insights into the safety profile of these chemical UV filters, contributing to the ongoing effort to ensure the efficacy and safety of organic sunscreens.