Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Hum
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 final administrative order (final order) (OTC000039) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human U
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-06-10 |
| Summary | 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 final administrative order (final order) (OTC000039) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information." This final order amends "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 is generally recognized as safe and effective (GRASE) if it meets the conditio |
| Document number | 2026-11578 |
| Official record | https://www.federalregister.gov/documents/2026/06/10/2026-11578/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-and |