Full Breakdown
FDA Approves Bemotrizinol, First New Sunscreen Ingredient in Over Two Decades
6/10/2026, 8:15:53 PM
Regulatory Milestone and Core Details
On June 9 2026 the U.S. Food and Drug Administration (FDA) added bemotrizinol (also called BEMT) to the over-the-counter sunscreen monograph—the first new active sunscreen filter approved since the late-1990s. The agency cleared the ingredient for concentrations up to 6 percent, deeming it safe for adults and children 6 months and older. Approval followed a seven-month review under the CARES Act-mandated streamlined process. Dutch firm DSM Nutritional Products will launch the first U.S. product, Parsol Shield, later in 2026; an 18-month exclusivity period will then allow other manufacturers to incorporate the filter.
Background & Context
U.S. sunscreens are regulated as drugs, a framework that has slowed the introduction of new filters for decades. The last FDA-approved ingredient before bemotrizinol was in 1999. In 2020 Congress enacted a reform (the CARES Act) to accelerate reviews, after criticism that the existing pathway left American consumers with fewer options than Europe, Australia, and Asia, where bemotrizinol has been used since 1999. Earlier FDA actions—banning “waterproof” claims in 2011 and proposing SPF caps and stronger UVA requirements in 2021—set the stage for this approval.
Key Figures & Organizations
- Robert F. Kennedy Jr., U.S. Secretary of Health and Human Services – announced the decision.
- Dr. Mike Davis, Acting Director, FDA’s Center for Drug Evaluation and Research – provided agency rationale.
- DSM Nutritional Products – applicant and exclusive marketer of the first U.S. bemotrizinol product.
- Environmental Working Group (EWG) – long-time advocate; chief science officer David Andrews and senior scientist Alexa Friedman issued statements.
- American Academy of Dermatology (AAD) – President Murad Alam, MD praised the public-health impact.
- Personal Care Products Council (PCPC) – industry trade group; spokesperson Tesia Williams voiced further regulatory expectations.
Data & Statistics
- Current U.S. sunscreens deliver only ? 24 % of the UVA protection implied by their SPF label (EWG analysis).
- Bemotrizinol blocks both UVA and UVB rays, is highly photostable, and shows minimal dermal absorption (< 1 %).
- The ingredient is approved for use in concentrations up to 6 % and will be available to all manufacturers after the 18-month exclusivity window.
- Skin-cancer incidence remains high; the American Cancer Society estimates > 200 000 melanoma cases in 2026, underscoring the need for broader UVA coverage.
Why It Matters
Broad-spectrum UVA protection is linked to reduced skin-cancer risk, lower photo-aging, and better immune-system preservation. Bemotrizinol’s stability means protection persists longer than many existing chemical filters, and its oil-soluble nature avoids the white cast typical of mineral filters (zinc oxide, titanium dioxide). By expanding the pool of approved filters, the FDA aims to stimulate competition, lower costs, and encourage formulation innovations that may improve consumer adherence to sunscreen use.
Official Statements & Responses
- HHS Secretary Kennedy highlighted the ingredient’s long safety record and its role in “advancing innovation” and competition.
- FDA’s Dr. Davis emphasized the agency’s commitment to “effective and safe therapies” for over-the-counter products.
- AAD President Alam called the approval “an important public-health step” for skin-cancer prevention.
- EWG’s Andrews described the decision as a “great day for American consumers” and a step toward closing the UVA protection gap.
- PCPC’s Williams praised the progress but urged the FDA to develop a “more efficient and modern approach” for future approvals.
Criticism & Opposition
The PCPC noted that while bemotrizinol’s clearance is positive, the broader regulatory framework still limits rapid entry of additional filters. Industry groups continue to request clearer labeling of active ingredients, standardized SPF and UVA metrics, and completion of pending FDA proposals on SPF caps and UVA thresholds.
Conflicting Reports & Gaps
Sources agree on the approval date and safety profile, but timelines for market availability differ: some reports state the first product will appear “later this year,” while others note that widespread shelf presence may not occur until after the 18-month exclusivity period. Long-term safety data on systemic absorption remain limited, and the FDA has not yet set a definitive schedule for evaluating other emerging filters.
Verbatim Quotes
- “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.” — Robert F. Kennedy Jr., U.S. Secretary of Health and Human Services
- “For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that.” — David Andrews, Environmental Working Group chief science officer
- “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.” — Dr. Mike Davis, Acting Director, FDA’s drug center
- “Bemotrizinol changes the calculus of sun care. It is highly photostable — meaning it won’t break down when hot summer sun hits your skin — unlike avobenzone, currently the only non-mineral filter in the U.S. that provides meaningful UVA coverage,” — Alexa Friedman, Senior Scientist, Environmental Working Group
- “While we commend FDA for this progress, continued efforts are needed to establish a more efficient and modern approach for approving additional sunscreen active ingredients,” — Tesia Williams, PCPC spokesperson
- “Bemotrizinol would be the first chemical UV filter recommended to be used on infants due to minimal skin irritation.” — Dr. Nisha Varadarajan, Dermatologist, Memorial Sloan Kettering Cancer Center
What’s Next
Parsol Shield is slated for a U.S. launch in late 2026. After the 18-month exclusivity window, other manufacturers may formulate sunscreens with bemotrizinol, potentially combining it with zinc oxide for enhanced broad-spectrum protection. The FDA continues to consider proposals on SPF caps, stronger UVA mandates, and streamlined pathways for future filters such as Mexoryl 400.
