The Food and Drug Administration (FDA) issued a proposed administrative order today to update its over-the-counter (OTC) Sunscreen Monograph, which will serve as a roadmap for manufacturers to bring OTC sunscreens to market and will provide a path to resolve outstanding questions about sunscreen ingredient safety and labeling. This long-awaited instruction, however, is not final. Before the agency moves forward, the Academy, industry, and other stakeholders will have the opportunity to comment.
Along with this decision, the FDA also published a deemed final order laying out all current FDA regulatory guidance on sunscreens, dating back to a 1999 final rule that was never enforced and the 2011 sunscreen labeling guidelines. The Coronavirus Aid Relief and Economic Security Act necessitated this publication, which essentially specifies the current sunscreen regulations. The proposed administrative order would update these existing regulations with the most up-to-date science and research, and it would supersede these previous acts once it is implemented.
The proposed directive essentially mirrors the proposed sunscreen rule released in 2019. Among the highlights are:
- SPF 60+ should be the maximum labeled value, with sunscreen products manufactured with SPF values up to 80 allowed to be marketed.
- Sunscreens comprising zinc oxide and titanium dioxide have been Generally Recognized as Safe and Effective (GRASE).
- Due of safety concerns, aminobenzoic acid (PABA) and trolamine salicylate are not GRASE.
- Because further evidence is needed to make a GRASE assessment, cinoxybenzone, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone are not GRASE.
- Broad spectrum standards must be met by all sunscreens with an SPF of 15 or higher.
- Updates to sunscreen product labels are being proposed, including an alphabetical listing of the active sunscreen components.
- Due to discrepancies in testing techniques between the FDA and the Environmental Protection Agency, sunscreen-insect repellent mixtures are not GRASE.
In response to this regulatory activity, the Academy has issued a press release and will develop educational materials to keep the public informed about the current developments in the field of sunscreen products.
The FDA’s aim to protect the public’s health by guaranteeing the safety and efficacy of sunscreen products is one that the Academy supports.