FDA Adds Bemotrizinol to the Sunscreen Monograph
The first new OTC sunscreen active ingredient in over 20 years comes with real conditions attached: permitted dosage forms, an excluded powder category, and evidence that must match the product you're actually building.
A Milestone With Conditions Attached
For the first time since the late 1990s, FDA has added a new active ingredient to the OTC sunscreen monograph. The addition of bemotrizinol gives U.S. formulators access to a broad-spectrum UVA/UVB filter that has been used internationally for years - but the authorization is not unconditional.
The decision is an important product-innovation milestone, and it's also a useful case study in modern product safety: a regulatory outcome depends not on the presence or absence of a chemical alone, but on the strength of the evidence for a defined ingredient, concentration, formulation, route of exposure, and intended use.
That distinction has direct, practical consequences for sunscreen manufacturers, ingredient suppliers, personal care companies, retailers, and product stewardship teams evaluating whether - and how - to bring bemotrizinol-based products to market.
What FDA Authorized
On June 10, 2026, FDA issued Final Administrative Order OTC000039, amending OTC Monograph M020.
Permitted Dosage Forms
FDA's order does not amount to an unrestricted approval of bemotrizinol in every type of sunscreen. It defines specific conditions for concentration, ingredient combinations, and dosage form.
Permitted Dosage Forms
- Oils
- Lotions
- Creams
- Gels
- Butters
- Pastes
- Ointments
- Sticks
- Pump sprays without a propellant
- Bag-on-valve spray systems (propellant isolated from formulation)
Not Yet Supported
- Powder sunscreens
- Conventional aerosols (propellant mixed directly with formulation)
Powder & Spray Exposure: Why It's the Crux of the Decision
FDA's dosage-form limitations reinforce a central principle of human health risk assessment: product safety cannot be characterized adequately without understanding how people may be exposed during actual use.
That principle is reflected in RHP Risk Management's own study of powder-form sunscreens containing titanium dioxide (TiO₂) and zinc oxide (ZnO). The study evaluated three commercially available products in a controlled clean-room environment, using a volunteer subject, real-time air monitoring, and laboratory-based particle analysis to characterize inhalation exposures during typical product application.
The work compared a hazard-minimization approach - focused on whether particles smaller than a specified size were present - with a human health risk assessment approach, which evaluated measured exposure in the context of toxicological thresholds and product-specific factors such as particle agglomeration and coating characteristics. Particle size alone does not quantify dose or determine the likelihood of an adverse health effect.
RHP's Exposure Science Laboratory characterizes inhalation exposure during actual product use, using real-time air monitoring and laboratory-based particle analysis to replace assumptions with measurements. See the ISES 2025 presentation on this work.
RHP's research did not evaluate bemotrizinol, and FDA's 2026 order did not authorize bemotrizinol in powder form. The connection is methodological: both illustrate why safety conclusions must be specific to the ingredient, formulation, delivery system, and exposure pathway being evaluated. Where data are incomplete, carefully designed exposure studies can replace assumptions with measurements and help identify what additional evidence is needed.
Formulation-Specific Evidence: Data Must Match the Product
For companies developing or evaluating sunscreen products, several lessons stand out from FDA's decision:
Ingredient status is only the starting point
A GRAS determination applies under specified conditions. Concentration, ingredient combinations, dosage form, manufacturing controls, packaging, labeling, and product performance all remain relevant.
Data must match the proposed product
Evidence developed for a cream or lotion does not automatically answer questions raised by a powder or aerosol. Delivery-system changes can change particle or droplet size, inhalation potential, deposition, and systemic uptake.
International experience informs, but doesn't replace, U.S. evidence
History of use and foreign-market data may be important lines of evidence, but must be integrated with the scientific and regulatory requirements applicable to the intended U.S. product.
Product stewardship should begin early
Exposure pathways, foreseeable use patterns, sensitive populations, toxicological endpoints, and data gaps are best evaluated during development, not after a formulation and delivery system have been finalized.
Clear risk communication matters
Companies need to explain what the available evidence does and does not establish, particularly when public discussion collapses hazard, exposure, and risk into a single question.
Commercial timing matters too: the 18-month statutory exclusivity described in FDA's order creates near-term considerations for ingredient sourcing, licensing, product-development timing, and market-entry strategy.
A2LA Accredited Exposure Sciences Laboratory
RHP's exposure testing is conducted in an A2LA-accredited laboratory - giving regulatory, legal, and customer audiences confidence in the data behind your product safety conclusions.
Learn About Our Accreditation →How RHP Supports Sunscreen & Personal Care Companies
RHP's Human Health Risk Sciences (HHRS) practice integrates exposure science, toxicology, epidemiology, and risk assessment to help organizations evaluate chemical risks across the product lifecycle. For sunscreen, cosmetic, personal care, and other consumer product clients, RHP can support:
The bemotrizinol decision expands the tools available to product innovators, but it also underscores the importance of evidence tailored to the product consumers will actually use. By integrating product testing with toxicology and exposure assessment, companies can make better-informed development decisions, support defensible safety conclusions, and prepare for regulatory and market scrutiny.
Meet the Experts
RHP's exposure scientists and toxicologists bring direct experience with sunscreen, cosmetic, and personal care product safety questions.
40+ years in toxicology and environmental health sciences, with deep expertise in chemical risk assessment for consumer and personal care products.
Former ATSDR/CDC and White House science policy leader; recognized PFAS and environmental epidemiology expert supporting ingredient safety evaluations.
25+ years in industrial hygiene and exposure assessment; leads exposure simulation studies at RHP's Exposure Sciences Laboratory.
20+ years in industrial hygiene, exposure reconstruction, and litigation support across consumer product and manufacturing sectors.
Specializes in probabilistic risk assessment, exposure and cancer risk analysis, and spatial/GIS modeling for product safety decisions.
Conference Presentations on Sunscreen & Mineral Ingredient Exposure
RHP's exposure scientists regularly present original research at the industry's leading scientific conferences.
Sunscreen Inhalation Safety at ISES 2025
Jacob Persky presented RHP's groundbreaking research on sunscreen inhalation safety, focusing on mineral (TiO2/ZnO) powder-form products and the difference between hazard-minimization and human health risk assessment approaches.
Read More →
Exposure, Hazard & Global Regulation of Mineral Active Ingredients
RHP experts Jacob Persky and Melanie C. Buser will join a panel examining the evaluation of mineral active ingredients used in sunscreen and personal care products, covering exposure, hazard, and the global regulatory landscape.
Read More →Is This Relevant to Your Role?
The bemotrizinol decision touches different parts of the organization in different ways.
Manufacturers
Evaluate whether bemotrizinol fits your product roadmap and permitted dosage forms.
Ingredient Suppliers
Understand exclusivity, sourcing, and licensing implications over the next 18 months.
Formulators
Match delivery-system decisions to the evidence FDA actually reviewed.
Regulatory Affairs
Track the CARES Act pathway and what it signals for future monograph requests.
Product Safety
Build exposure evidence before a formulation and delivery system are finalized.
R&D Leaders
Plan testing programs that close data gaps early, not after launch.
Bringing Bemotrizinol to Market? Let's Talk Evidence.
Whether you're evaluating a new formulation, closing a data gap, or preparing a risk communication strategy, RHP's exposure scientists and toxicologists can help you build a defensible, product-specific evidence package.