Background

The FDA seeking public input by Nov. 12 on a proposal to improve the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter drugs. Among other things, the agency is proposing revisions and updates to the requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum, and product labeling.

The FDA indicates that the proposed provisions are substantively the same as those described in its 2019 proposed rule on sunscreens and are aimed at “bringing sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective sunscreen products.” For example, the proposal would update the generally recognized as safe and effective (GRASE) status for 16 active ingredients, establish that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and grant GRASE status for spray sunscreens subject to testing and labeling requirements.

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