FDA Proposes First New Sunscreen Active Ingredient in Two Decades

On December 12, the FDA issued a proposed administrative order that would add bemotrizinol to the sunscreen monograph. If finalized, this would be the first new sunscreen active added since 1999 and would immediately affect formulators, US market-entry strategies, and global harmonization efforts across the pharmaceutical and cosmetic sectors.

In the United States, sunscreens are regulated 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 impermissible claims), and SPF/broad-spectrum testing procedures. Currently, 16 active ingredients are permitted.

A (Very) Brief History of US Sunscreen Regulation: From Rulemaking to Orders

The FDA’s sunscreen framework has evolved over more than five decades — from an advance notice of proposed rulemaking in 1978 to a tentative final monograph in 1993, to a final monograph published (but stayed) in 1999, to interim guidance issued in 2011 and finalized in 2018.

The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) replaced the rulemaking process for OTC monograph drugs with an administrative order for issuing, revising, and amending the monograph. The CARES Act also established deemed final orders for certain OTC monographs, including M020. The FDA issued the sunscreen deemed final order in September 2021 and, concurrently, proposed updates to align testing and labeling with current science. When finalized, those updates will replace the deemed final order.

What the FDA Is Proposing Now

The FDA received an OTC Monograph Order Request from DSM Nutritional Products LLC on September 23, 2024, seeking GRASE status for bemotrizinol. After review, the FDA has proposed to amend M020 to add bemotrizinol as a permissible sunscreen active ingredient.

Under the proposed order, bemotrizinol-containing sunscreen products would be considered GRASE if they satisfy all conditions in M020, including the following new or clarified elements:

• Concentration Limit: Up to 6% bemotrizinol.

• Combinations: Bemotrizinol may be combined with other sunscreen actives and skin protectant actives, consistent with monograph conditions.

• 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.

The proposal is open for public comment until January 26.

Practical Implications for Industry

The addition of bemotrizinol (at up to 6%) creates, for the first time in over 20 years, a pathway to market novel sunscreen formulations using a new active or new combination of actives.

Companies interested in developing new products or reformulating existing products utilizing bemotrizinol should:

• Evaluate Portfolio Fit: Determine if and where bemotrizinol might enhance UVA/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.

Given the short comment window and the technical significance of formulation and delivery-system conditions, data-driven comments may be particularly valuable. Companies may want to consider addressing concentration, ingredient combinations, dosage forms (including aerosolization mechanics), and any implementation considerations for scaling compliant packaging technologies.

Next Steps for Industry

Interested industry members should review the proposed order and identify any formulation, packaging, or labeling implications for current or planned products using bemotrizinol. If desired, such companies should additionally prepare and submit comments to the FDA by January 26. This is a valuable opportunity to raise any issues or concerns with amending M020 as proposed by the agency. Finally, interested parties should monitor the FDA’s site and the Federal Register for any updates and for the final administrative order, including any refinements to dosage-form allowances or combination rules.

If you would like assistance with submitting a comment on the proposed rule, are interested in learning more about FDA regulation of sunscreen products, or are seeking guidance on any of the above, please contact the authors.