Sunscreen drug products; Domestic safety (ICS 13.120), Products of the chemical industry (ICS 71.100).

Sunscreen Drug Products for Over-the-Counter Human Use

The Food and Drug Administration (FDA or Agency) has extended the comment period for the over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled "Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use" (Proposed Order), which was issued on 24 September 2021. A notice of availability for the Proposed Order appeared in the Federal Register of 27 September 2021. FDA issued the Proposed Order to amend and revise the deemed final administrative order concerning non-prescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which non-prescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth certain characteristics that would establish that a sunscreen drug product is not GRASE. FDA has extended the comment period for the Proposed Order in response to a request for an extension to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the Proposed Order issued on 24 September 2021 (86 FR 53322) to 27 December 2021.