Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability

Issuing agencies

Abstract

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.