FDA approves bemotrizinol, a new sunscreen ingredient, giving Americans access to a widely used European UV filter
The FDA on June 9, 2026 approved bemotrizinol as a new OTC sunscreen active ingredient, authorized up to 6% for people 6 months and older — the first U.S. sunscreen filter added to the monograph in more than 25 years.
- First OMOR success: Bemotrizinol was added to OTC monograph M020 via the OMOR pathway, marking the first new sunscreen filter added in roughly 25–30 years.
- Approved use: Up to 6% concentration for people aged 6 months and older; ingredient characterized as GRASE by the FDA.
- Market rollout: DSM‑Firmenich will market the filter as Parsol Shield, with an 18‑month exclusivity period before others may rely on the OMOR.
- Public health impact: Photostable, broad UVA/UVB coverage and low absorption may improve formulation options and consumer uptake.
What the FDA did
Final administrative order (June 9, 2026): The Food and Drug Administration issued a final order adding bemotrizinol to the U.S. OTC sunscreen monograph M020 after reviewing safety and effectiveness data submitted in an OMOR filed by DSM Nutritional Products LLC on September 23, 2024. The move follows a proposed order and public comment period in December 2025 and uses the streamlined OMOR pathway created under the 2020 CARES Act.
Source: FDA press announcement: FDA expands sunscreen options for the first time in 20 years
Safety and effectiveness: what the FDA concluded
The FDA’s review concluded that bemotrizinol:
- Provides broad‑spectrum protection against UVA and UVB radiation, supporting broad‑spectrum labeling.
- Shows low systemic absorption in typical use; plasma levels in submitted studies rarely exceeded FDA safety benchmarks.
- Causes minimal irritation in the data reviewed.
On this basis, the agency determined bemotrizinol to be GRASE for OTC sunscreen products for adults and children aged 6 months and older at concentrations up to 6%.
Related materials: FDA proposed expansion notice and a peer‑reviewed review: Peer‑reviewed review on modern UV filters (bemotrizinol).
How and where bemotrizinol can be used
Under the amended monograph, bemotrizinol may be included in many common sunscreen forms — oils, lotions, creams, gels, butters, pastes, ointments, sticks and certain non‑propellant and isolated‑propellant spray products. Finished products still must meet SPF and broad‑spectrum testing rules, display proper Drug Facts labeling, and follow monograph conditions before marketing.
Legal and regulatory guidance for manufacturers: see analysis by legal advisers such as Diaz Trade Law overview of the new sunscreen active ingredient and commentary from Holland & Knight (HKLaw) on the FDA proposal.
Product name, exclusivity and market timing
Initial U.S. product: DSM‑Firmenich will market bemotrizinol as Parsol Shield, with DSM expecting product launches in 2026. An 18‑month exclusivity tied to DSM’s OMOR filing prevents other firms from relying on that OMOR during the exclusivity window; afterward, other manufacturers may develop products using the filter subject to monograph rules.
Industry reporting and timing estimates suggest consumer brands could roll out new products within 3–6 months after approval depending on supply chains and formulation development. See industry coverage: HealthCentral on new sunscreen formulas and timing.
Why this matters: regulatory modernization and global context
For decades the U.S. lagged behind regions like Europe and Australia in approving modern UV filters. Bemotrizinol has been used internationally for its photostability and broad UVA/UVB coverage; some regions have allowed up to 10% while Canada allowed 6%. The long pause in U.S. approvals reflected limitations of the older OTC monograph process; the OMOR pathway created by the CARES Act has streamlined review and enabled this addition.
FDA leadership view: Commissioner Marty Makary, MD, MPH, said the agency is “continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” and emphasized timely access to safe, effective OTC products.
Karen Murry, MD, acting director of the Office of Nonprescription Drugs, called bemotrizinol “a welcome addition” and noted the FDA’s intent to work with other companies on bringing new active ingredients to market more quickly.
Source: FDA press announcement
Relationship to broader sunscreen policy and public health guidance
This approval does not change core sun‑safety advice. Public‑health guidance continues to recommend broad‑spectrum sunscreens with SPF 15 or higher (many experts recommend SPF 30+ for daily use), along with reapplication, protective clothing and shade. Bemotrizinol’s characteristics may help formulators produce less greasy, longer‑lasting and better UVA‑protective products — features that could improve adherence to sunscreen use and reduce sunburn and long‑term risks like skin cancer and photoaging.
The FDA continues to evaluate safety data for some older filters under modern standards; post‑market monitoring will be important for rare adverse reactions and environmental fate concerns.
Implications for the world: industry, consumers and regulators
Economic and industry impact: U.S. approval narrows gaps between global markets, allowing consistent formulas across regions, potentially lowering development costs and speeding global launches.
Consumer and health implications: Wider use of modern filters like bemotrizinol could yield more durable, broad‑spectrum sunscreens that encourage regular use, when combined with other sun‑safe behaviors.
Regulatory and environmental considerations: If the OMOR pathway continues to add modern actives, more global filters could reach U.S. shelves; watchdogs will monitor post‑market data on absorption, environmental fate, and rare adverse reactions.
Practical takeaway for consumers and manufacturers
- Consumers: Look for broad‑spectrum SPF on labels, follow reapplication guidance, and use sunscreen as one part of layered sun protection.
- Manufacturers: Ensure formulations meet monograph testing, labeling, and registration requirements. Expect DSM’s Parsol Shield products first, then other brands after the 18‑month exclusivity.
Sources and further reading
- FDA press announcement: FDA expands sunscreen options for the first time in 20 years
- FDA proposed expansion notice
- Peer‑reviewed review on modern UV filters (bemotrizinol)
- Diaz Trade Law overview of new sunscreen active ingredient
- Holland & Knight / HKLaw analysis of FDA proposal and process
- HealthCentral coverage on new sunscreen formulas and timing
- FDA Q&A on deemed final order and proposed order over‑the‑counter sunscreen
Preserved facts, sources and original URLs included above. For implementation and regulatory compliance, consult the primary FDA order and the legal analyses linked in Sources.
