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FDA Pushes Higher Limits, New Labeling and More Data for Sunscreens via Cosmetics & Toiletries

The U.S. Food and Drug Administration (FDA) is proposing updates to its regulatory requirements that will impact many U.S.-marketed sunscreens. According to the firm, this action aims to bring nonprescription, over-the-counter (OTC) sunscreens that make unapproved claims up to date with the latest science.

The proposed rule, which will officially be published for comment on Feb. 26, 2019, addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make key product information easier for consumers to identify.

Proposed Changes

Following are the proposed updates:

More data on actives. Of the 16 currently marketed active ingredients, two, i.e, ZnO and TiO₂, are generally recognized as safe (GRASE) for use in sunscreens; two others, PABA and trolamine salicylate, are not GRASE for sunscreens. The remaining 12 have insufficient data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is seeking additional data.

Review of powders and other product forms. Dosage forms that are GRASE for use as sunscreens include: sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks. Powders are proposed to be eligible for inclusion in the monograph but additional data is requested.
Further, wipes, towelettes, body washes, shampoos and other dosage forms are proposed to be categorized as new drugs since the FDA has not received data showing they are eligible for inclusion in the monograph.