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, Agency, or we) is announcing the availability of an 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." FDA is issuing this proposed order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription 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 also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE.
DATES: Submit electronic comments on the proposed order by 11:59 p.m. Eastern Time at the end of 12 November 2021.