Here Comes the Sun(screen): FDA Greenlights Bemotrizinol as Active Ingredient

As we explained in our January alert, sunscreens are regulated in the United States as over-the-counter (OTC) drugs under the deemed final order for Sunscreen Drug Products for OTC Human Use (M020). Sunscreen products marketed with cosmetic claims (e.g., claims to beautify, alter appearance, etc.) are treated as combination drug-cosmetic products and must meet both OTC drug and cosmetic requirements. 

M020 establishes the conditions under which sunscreen products are generally recognized as safe and effective (GRASE), including permissible active ingredients (and combinations of active ingredients), labeling requirements (e.g., directions, water-resistance statements, warnings, and required or prohibited claims), and SPF/broad-spectrum testing procedures. Prior to this latest action, only 16 active ingredients were permitted.

The Final Order

The June 10 final order follows the FDA’s proposed order issued on December 12, 2025, after DSM Nutritional Products LLC submitted a Tier 1 OTC Monograph Order Request seeking GRASE status for bemotrizinol. Per the Federal Register notice, the FDA reviewed comments on the proposed order but ultimately made no changes to the final order. 

As finalized, the order amends M020 to permit the use of bemotrizinol as an active ingredient in sunscreen products subject to certain conditions. This action represents the first addition of a new sunscreen active ingredient to the OTC sunscreen monograph since 1999, and the first such addition under the streamlined OTC monograph administrative order process established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

Bemotrizinol is a broad-spectrum sunscreen active ingredient that provides protection against both ultraviolet A and ultraviolet B rays and has been marketed as a sunscreen ingredient in Europe and many other countries for years. According to the FDA, the ingredient has low levels of absorption through the skin, and the agency considers bemotrizinol GRASE for use in sunscreens by adults and children six months of age and older.

Under the final order, bemotrizinol-containing sunscreen products are considered GRASE if they satisfy all conditions in M020, as amended by the order, including the following key conditions:

• Concentration Limit: Up to 6% bemotrizinol.
• Combinations: Bemotrizinol may be combined with other sunscreen actives and certain skin protectant actives, consistent with monograph conditions. However, combinations with para-aminobenzoic acid or trolamine salicylate are not permitted. 
• Dosage Forms: Oil, lotion, cream, gel, butter, paste, ointment, stick, and spray. For sprays, the product must be manufactured and packaged either without a propellant or in a container-closure system that isolates the propellant from the formulation so there is no propellant-formulation contact. Directly propellant-combined aerosol sprays and powder dosage forms are not permitted under the order.

Practical Implications for Industry

For industry, the final order creates an immediate new pathway for sunscreen manufacturers, formulators, and brand owners to develop or reformulate OTC sunscreen products using bemotrizinol (at concentrations up to and including 6%), provided the products comply with all applicable conditions in M020 and other OTC drug requirements. 

As discussed previously, companies evaluating whether to develop and market bemotrizinol-containing sunscreen products should:

• Evaluate Portfolio Fit: Determine if and where bemotrizinol might enhance UVA and UVB coverage and product positioning.
• Plan Validation and Labeling: Align with M020’s labeling and SPF and broad‑spectrum testing requirements and prepare for any new claims substantiation.
• Ready Manufacturing Lines: Evaluate packaging and fill capabilities, especially for spray dosage forms that require propellant isolation. 

Companies considering new or reformulated sunscreen products should review the final order and M020 and confirm that planned products meet all amended monograph conditions before marketing. 

If you are interested in learning more about FDA regulation of sunscreen products, or are seeking guidance on any of the above, please contact the authors.