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

Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use Sunscreen Drug Products for Over-the-Counter Human Use

In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000039) entitled ''Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use.'' This proposed order, if finalized, will amend Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient. A sunscreen drug product containing bemotrizinol would be generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by this proposed order, if finalized.

Submit electronic comments on the proposed order by 26 January 2026.