FDA Moves to Improve Safety and Efficacy of Sunscreen Products

The FDA on Sept. 27 released recommended revisions and updates to a proposed order concerning maximum sun protection factor (SPF) values, active ingredients, product labeling and other issues associated with over-the-counter sunscreens.

A statement released by the agency characterizes the proposed updates as “substantially the same” as the 2019 proposed order written to ensure sunscreens are developed using the latest relevant science. In part, the FDA proposes to update the GRASE (generally recognized as safe and effective) status for the 16 active ingredients listed in the deemed final order. It also proposes potential testing and labeling requirements for dosage forms that are GRASE for use as sunscreens including oils, lotions, creams, gels, butters, pastes, ointments and sticks, and proposes GRASE status for spray sunscreens.

According to the FDA, the order’s proposals related to SPF and broad spectrum are designed to ensure that consumers have access to sunscreens with adequate ultraviolet A rays (UVA) protection, given the growing body of data linking UVA exposure to skin cancers and other harms. The order also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

The agency will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order (and is considering all comments timely submitted to the 2019 proposed rule to be constructively submitted to the proposed order; the deadline is Nov. 12, 2021). The effective date of the revised final order cannot be sooner than one year after its issuance.

Broad spectrum sunscreens with SPF values of at least 15 are only one element of a skin-cancer prevention strategy. Other sun protective behaviors include: wearing protective clothing that adequately covers the arms, torso and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight.

Helpful Links

FDA Press Release: https://tinyurl.com/ezkdapfv

Federal Register Comments: https://tinyurl.com/z3j3u5w2

Final Order: https://tinyurl.com/6xd6577r

Labeling and Effectiveness Testing Rule: https://tinyurl.com/7cypm8wp