Final Order | Order Number OTC000039 | View Federal Register Notice ⬈
Order Title: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
Summary
In response to an over-the-counter (OTC) monograph order request (OMOR), FDA is issuing Final Administrative Order OTC000039 (final order) to amend the requirements for sunscreen drug products for OTC human use in Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020).
This final order amends OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient. The final order establishes 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.
The proposed order and supporting documents can be found in the History section below.
Current Orders
| Published Date | Document Title | Supporting Documents |
|---|---|---|
| 6/10/2026 | Final Order |
Scientific Review |
History
| Published Date | Document Title | Supporting Documents |
|---|---|---|
| 12/12/2025 | Proposed Order | Navigate to Supporting Documents |
Additional Information
| Published Date | Topic | Documents |
|---|---|---|
| 06/10/2026 | Environmental |
Requestor's Environmental Assessment FDA's Finding of No Significant Impact (FONSI) FDA's Scientific Review of Requestor's Environmental Assessment |