Yesterday, the U.S. Food and Drug Administration (FDA) issued a proposed administrative order to amend its over-the-counter (OTC) monograph for sunscreens to authorize the use of a new active ingredient, bemotrizinol. This development is significant in two ways: first, it marks the first time FDA has authorized a new OTC sunscreen active ingredient in over 25 years, which may signal a renewed interest in supporting innovation in the sunscreen market. Second, it marks the first time FDA has issued a proposed order in response to an industry-initiated OTC monograph order request (OMOR), potentially offering a blueprint for stakeholders looking to leverage this pathway moving forward. We discuss both of these points in more detail below.
I. Potential implications for the OTC sunscreen market.
Most sunscreen products available in the United States are marketed under FDA’s OTC monograph for sunscreen products, which allows for the use of 16 active ingredients in sunscreens—the same 16 active ingredients that FDA first authorized for use in sunscreens in the 1990s. While there have been numerous attempts to amend the sunscreen monograph in the intervening decades, none have led to the authorization of new active ingredients. This is despite the fact that several additional active ingredients have long been used in sunscreens sold in other countries and have been shown to be safe and effective for this purpose.
FDA’s proposed order would break this logjam by authorizing a new sunscreen active ingredient, bemotrizinol, at concentrations up to 6 percent in products with a minimum sun protection factor (SPF) value of at least 2. The proposed order would subject bemotrizinol sunscreens to the same labeling requirements as other OTC monograph sunscreens and would allow for the use of bemotrizinol in combination with other authorized sunscreen active ingredients (except aminobenzoic acid (PABA) and trolamine salicylate) and certain skin protectant ingredients authorized under FDA’s OTC monograph for skin protectant drug products. The proposed order would allow sunscreens containing bemotrizinol to be marketed in oil, lotion, cream, gel, butter, paste, ointment, stick, and non-aerosol spray dosage forms.
FDA issued this proposed order in response to an industry-initiated OMOR. To support its request, the requestor submitted a combination of nonclinical studies (including a dermal carcinogenicity study and developmental and reproductive toxicity studies), human clinical studies (including human clinical efficacy studies, a human dermal pharmacokinetic (MUsT) study, other dermal studies), and postmarket safety reports from other countries that allow bemotrizinol sunscreens. Stakeholders have until January 26, 2026, to submit comments on the proposed order.
The proposed order could provide a helpful benchmark for stakeholders considering what data may support similar requests. Moreover, the mere fact that FDA has advanced this OMOR may signify a renewed interest in supporting innovation in the sunscreen market, including through the approval of additional actives ingredients.
II. Potential implications for the broader OTC market.
The OMOR pathway was created through the OTC monograph reforms included in the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established a new “administrative order” system for adding, removing, or modifying OTC monographs. Under this system, industry stakeholders can seek monograph changes (including approval of new active ingredients) by submitting an OMOR. FDA, in turn, is required to assess OMORs against specified statutory criteria and, if certain conditions are met, issue a proposed administrative order, solicit public comment, and issue a final administrative order. FDA can also issue proposed orders at its own discretion, without submission of an OMOR.
This administrative order system was intended to create an efficient alternative to the cumbersome notice-and-comment rulemaking process FDA previously had to complete when issuing or amending OTC monographs. In practice, however, FDA has been relatively slow to implement this system and, while it has issued a handful of agency-initiated proposed orders (including a statutorily-mandated proposed sunscreen order), it has not, until now, issued any proposed orders in response to an OMOR request. Issuance of this bemotrizinol order could be an encouraging sign that the agency is prepared to begin conducting OMOR reviews more expeditiously and could serve as a helpful blueprint for stakeholders hoping to leverage this pathway. This would be consistent with commitments FDA made as part of the recent OTC Monograph Drug User Fee Program (OMUFA) reauthorization (which included performance goals related to the review of OMOR submissions) and would align with FDA’s recent efforts to explore strategies for increasing access to OTC drugs, including the issuance of a recent request for information on that topic.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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