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Administrative Order Details


Order Title: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (ID: OTC000008) - Federal Register Notice


Proposed Order


This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  It also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE, proposed to be codified in “Non-Monograph Conditions NM020:  Sunscreen Drug Products for Over-the-Counter Human Use.” This proposed order also proposes to amend and revise “OTC Monograph M016, Skin Protectant Drug Products for Over-the-Counter Human Use,” to address nonprescription sunscreen drug products that are also subject to provisions of that monograph.

You may submit comments for OTC000008 electronically in docket number FDA-1978-N-0018 in the Federal eRulemaking Portal at https://www.regulations.gov.  Comments must be submitted by December 27, 2021; FDA granted an extension of the public comment period on November 12, 2021. (See 86 FR 66318 (Nov. 22, 2021). This Federal Register notice regarding the extension also provides instructions for submitting comments.) Supporting documents can be viewed in the docket.

FDA will consider all comments that were timely submitted to the public docket for the 2019 proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use”, (84 FR 6204 (Feb. 26, 2019)), to be constructively submitted as comments on the proposed order issued September 24, 2021.  To enable the Agency to review and address these comments (and future comments that may be submitted on this proposed order) as expeditiously as possible, we request that commenters do not resubmit comments on this proposed order previously submitted on the proposed rule.


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