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

Summary

In response to an OTC monograph order request (OMOR), FDA is issuing this proposed administrative order (proposed order) to amend the requirements for sunscreen drug products for over-the-counter (OTC) human use in Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020).

This proposed order, if finalized, will amend OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient. If finalized, the proposed order would establish that for a drug product containing bemotrizinol as a sunscreen active ingredient to be legally marketed without an approved application under section 505 of the FD&C Act, among other requirements, it must conform to certain conditions that address the concentration of bemotrizinol in the drug product, permitted combinations of bemotrizinol with other sunscreen active ingredients and with skin protectant active ingredients, and permitted dosage forms.

You may submit comments on this proposed order (OTC000039) electronically in docket number FDA-2025-N-6494 in the Federal eRulemaking Portal at https://www.regulations.gov/.

See the proposed order for instructions. Comments will be accepted at any time beginning on December 12, 2025 until 11:59 pm Eastern Time at the end of January 26, 2026.

The Scientific Review Supporting Proposed Administrative Order OTC000039 can be viewed under the Supporting Documents. Additionally, data and information submitted by the Requestor in the OMOR can also be viewed under the Supporting Documents.

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