On June 9, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order (OTC000039), officially adding Bemotrizinol (Bis-ethylhexyloxyphenol methoxyphenyl triazine) to the Over-the-Counter (OTC) Monograph M020 (Sunscreen Drug Products) as a permitted active ingredient. This marks the first addition of a new active ingredient to the U.S. OTC sunscreen monograph since the late 1990s, representing a significant milestone in the modernization of the country's sunscreen regulatory framework. The final order will take effect on August 9, 2026.
Overview of Bemotrizinol
Bemotrizinol is a broad-spectrum ultraviolet (UV) filter that provides protection against both UVA and UVB radiation, with very low percutaneous absorption. The ingredient has been used safely in Europe and international markets for many years. Based on FDA's evaluation, Bemotrizinol has been determined to be "Generally Recognized as Safe and Effective" (GRASE) for use in sunscreen products for adults and children 6 months of age and older.
Regulatory Timeline
The regulatory timeline for this approval is as follows:
- September 23, 2024: DSM Nutritional Products LLC submitted an OTC Monograph Order Request (OMOR) to the FDA, requesting the addition of Bemotrizinol (at concentrations up to 6%) as a new active ingredient to OTC Sunscreen Monograph M020.
- December 12, 2025: The FDA issued a proposed administrative order for public comment, with the comment period running from December 12, 2025 to January 26, 2026.
- June 9, 2026: After reviewing public comments, the FDA issued Final Administrative Order OTC000039, officially approving Bemotrizinol for inclusion in the OTC sunscreen monograph. The process from proposed order to final order took only approximately 7 months.
- August 9, 2026: The final order will officially take effect.
Key Regulatory Points
GRASE Determination: The FDA has determined Bemotrizinol to be a GRASE ingredient, suitable for use in sunscreen products for individuals 6 months of age and older.
Maximum Use Concentration: Bemotrizinol is permitted in sunscreen formulations at concentrations up to 6%.
Permitted Dosage Forms: Bemotrizinol may be used in oil, lotion, cream, gel, butter, paste, ointment, stick, and spray dosage forms. For spray products, the product must be manufactured and packaged with no propellant, or use a spray delivery system where all propellant is isolated from the drug product formulation.
Combinatorial Use: Bemotrizinol may be combined with other approved sunscreen active ingredients in the monograph.
CARES Act Pathway: This is the first new sunscreen active ingredient added through the streamlined OTC monograph administrative order process established by the CARES Act.
Key Takeaways
Milestone Significance: Bemotrizinol is the first new active ingredient added to the U.S. OTC sunscreen monograph since the late 1990s.
Regulatory Efficiency: The process from proposed order to final order took only approximately 7 months, demonstrating the efficiency of the OTC monograph amendment process under the CARES Act.
Formulation Flexibility: Provides U.S. sunscreen manufacturers with additional formulation options, helping to close the gap with other global markets.
Alignment with MAHA Strategy: This approval aligns with the priority set forth in the U.S. government's "Make America Healthy Again" (MAHA) Strategy Report regarding the promotion of innovation in the sunscreen market.
The Global Regulatory Status of Bemotrizinol
According to the Global CosIng database: In the European Union, Bemotrizinol is listed in Annex VI (permitted UV filters) of Regulation (EC) No 1223/2009, with a maximum allowable concentration of 10% in cosmetic products.
In China, it is included in the Safety and Technical Standards for Cosmetics, Table 5 (permitted UV filters), with a maximum allowable concentration of 10% in cosmetic products.
CIRS Reminder
The FDA's approval of Bemotrizinol presents new market opportunities for sunscreen product companies. Relevant companies should pay attention to the following:
- Monitor the effective date: The final order will officially take effect on August 9, 2026. Companies should plan their product development and launch timelines accordingly.
- Ensure compliance: Although OTC sunscreen products do not require separate drug application approval, they must meet all conditions specified in Monograph M020, including requirements for active ingredients, indications, dosages, and labeling.
- Stay updated on regulatory developments: The FDA may continue to approve additional new sunscreen ingredients through the OTC monograph administrative order process. Companies should closely monitor regulatory updates.
About CIRS
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards.
We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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