SUPPLEMENTARY INFORMATION:

I. Background

FDA is issuing final order OTC000008-1 to amend the requirements for sunscreen drug products for OTC human use, as described in OTC Monograph M020, to remove PABA and trolamine salicylate as sunscreen active ingredients. FDA is issuing the final order pursuant to section 505G(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(b)(1)).

OTC Monograph M020 describes the conditions under which OTC sunscreen drug products are GRASE under section 201(p)(1) of the FD&C Act (21 U.S.C. 321(p)(1)). OTC Monograph M020 was previously set forth in final order OTC000039, issued on June 10, 2026. The conditions described in OTC Monograph M020 may be amended, revoked, or otherwise modified in accordance with the procedures of section 505G(b) of the FD&C Act.

Final order OTC000008-1 amends the conditions described in OTC Monograph M020, as set forth in final order OTC000039, to remove PABA and trolamine salicylate as sunscreen active ingredients. FDA has determined that there are no conditions under which a drug product containing PABA or trolamine salicylate as a sunscreen active ingredient is GRASE under section 201(p)(1) of the FD&C Act because FDA's review of the available safety data for PABA and trolamine salicylate shows that the risks associated with use of these active ingredients in sunscreen drug products outweigh the benefits.

A notice of availability of the proposed order OTC000008 titled “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use” was announced in the Federal Register on September 27, 2021 (86 FR 53322) (comment period extended November 22, 2021 (86 FR 66318)). FDA proposed to establish certain new conditions under which nonprescription sunscreen drug products would be determined to be GRASE. Relevant to this final order, FDA proposed to amend OTC Monograph M020 to remove PABA and trolamine salicylate as sunscreen active ingredients because FDA's review of the available safety data for PABA and trolamine salicylate shows that the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits. FDA considered timely submitted comments on the proposal to amend OTC Monograph M020 to remove PABA and trolamine salicylate as sunscreen active ingredients, and after considering comments, FDA in this final order OTC000008-1 finalizes its proposed determinations regarding sunscreen drug products containing PABA and trolamine salicylate without change. FDA will address the other aspects of proposed order OTC000008 in a future order or orders.

II. Paperwork Reduction Act of 1995

Final order OTC000008-1 is issued under section 505G(b)(1) of the FD&C Act. Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 (PRA) (Chapter 35 of title 44, United States Code) does not apply to collections of information made under section 505G of the FD&C Act. Therefore, clearance by the Office of Management and Budget under the PRA is not required for collections of information, if any, in a final order issued under section 505G of the FD&C Act.

III. Electronic Access

The final order can be accessed on the OTC Monographs@FDA portal at www.accessdata.fda.gov/​scripts/​cder/​omuf/​index.cfm. Under the “Administrative Orders” banner, click on the desired link under the “Order ID” heading and follow the prompts. FDA established this information technology system with a web portal that can be accessed through FDA's website. The OTC Monographs@FDA portal provides a resource for the public to view administrative orders (proposed, final, and interim final orders), as well as related supporting documents, for OTC Monograph Drugs and view OTC Monographs. In the future, the OTC Monographs@FDA portal will facilitate the public's ability to submit, search, and view comments and data for proposed and interim final orders.

91 FR 57892