FDA Approves Bemotrizinol as First New Chemical Sunscreen Ingredient in Over 20 Years
On June 10, 2026, the U.S. Food and Drug Administration (FDA) issued a final administrative order adding bemotrizinol (BEMT) to the list of permissible over-the-counter (OTC) sunscreen active ingredients in the United States. This historic decision marks the first new chemical sunscreen active ingredient approved in the US in over 25 years (since 1999) and represents a massive victory for dermatologists, consumers, and the personal care industry.
Regulatory Context and the CARES Act
Historically, the FDA has regulated sunscreen filters as over-the-counter drugs rather than cosmetics, subjecting them to rigorous Generally Recognized as Safe and Effective (GRASE) requirements. This regulatory stance created a decades-long bottleneck, preventing advanced UV filters widely used in Europe, Asia, and Australia since the 1990s from entering the US market. The Sunscreen Innovation Act of 2014 failed to resolve the backlog.
The breakthrough was ultimately enabled by the CARES Act of 2020, which overhauled the OTC drug monograph system and established a streamlined administrative order process supported by industry user fees. This was further bolstered by the SAFE Sunscreen Standards Act signed into law in 2025, directing the FDA to streamline its review of sunscreen active ingredients. Bemotrizinol is the first sunscreen filter to navigate this newly modernized regulatory pathway successfully.
Scientific and Cosmetic Advantages
Bemotrizinol is a highly effective, organic (chemical) broad-spectrum filter that absorbs both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. Unlike other chemical filters currently permitted in the US (such as avobenzone, oxybenzone, or octocrylene), bemotrizinol is:
- Highly Photostable: It does not degrade rapidly when exposed to sunlight, maintaining its protective capabilities over time.
- Low Skin Absorption: Clinical data reviewed by the FDA demonstrates that bemotrizinol has minimal systemic absorption into the bloodstream, addressing a major safety concern associated with older organic filters.
- Cosmetically Elegant: Unlike mineral filters (zinc oxide and titanium dioxide) which leave a heavy white cast on the skin, bemotrizinol is clear and has a pleasing texture, making consumers more likely to apply and reapply it.
- GRASE Recognized: It is the only chemical filter on the US market recognized as Generally Recognized as Safe and Effective (GRASE) for adults and children aged six months and older.
Final Order Formulation Conditions
The FDA's final administrative order amends the OTC Sunscreen Monograph (M020) to permit the use of bemotrizinol under specific conditions:
- Concentration Limit: Formulations may contain up to 6% bemotrizinol.
- Permitted Dosage Forms: Oils, lotions, creams, gels, butters, pastes, ointments, sticks, and sprays.
- Spray Restrictions: Aerosol sprays directly combined with propellant are not permitted. Sprays must be manufactured either without a propellant (e.g., pump sprays) or in a container-closure system that isolates the propellant from the sunscreen formulation.
- Prohibited Combinations: Combinations of bemotrizinol with para-aminobenzoic acid (PABA) or trolamine salicylate are prohibited.
Commercial Launch and Pipeline Plans
The final administrative order was initiated by a Tier 1 OTC Monograph Order Request from DSM-Firmenich (formerly DSM Nutritional Products LLC), which will market the ingredient under the brand name PARSOL® Shield.
Under the terms of the approval, DSM-Firmenich holds exclusive marketing rights to bemotrizinol in the US for the first 18 months, acting as the sole supplier of the filter during this period. Sunscreen manufacturers can begin incorporating bemotrizinol into US products starting August 9, 2026.
Skincare giant Kenvue has already confirmed plans to integrate bemotrizinol into its Neutrogena and Aveeno sunscreen pipelines to leverage its safety and aesthetic benefits.