Product Safety | Regulatory Insight

For the first time since the late 1990s, the U.S. Food and Drug Administration (FDA) has added a new active ingredient to the over-the-counter (OTC) sunscreen monograph. The addition of bemotrizinol gives U.S. formulators access to an ultraviolet filter that has been used internationally for years and offers broad-spectrum protection against both UVA and UVB radiation.

The action is an important public health and product-innovation milestone. It is also a useful case study in modern product safety: a regulatory decision 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 practical consequences for sunscreen manufacturers, ingredient suppliers, personal care companies, retailers, and product stewardship teams.

What Did FDA Authorize and What Did It Leave Out?

On June 10, 2026, FDA issued Final Administrative Order OTC000039, amending OTC Monograph M020 to permit bemotrizinol as a sunscreen active ingredient at concentrations up to 6%. The order took effect August 9, 2026.

FDA determined that bemotrizinol is generally recognized as safe and effective (GRAS) under the conditions established in the order for use by adults and children six months of age and older. The agency based its decision on its review of clinical and nonclinical safety information, clinical efficacy studies, clinical pharmacology data, literature, and public comments. FDA also noted that bemotrizinol provides UVA and UVB protection and has low systemic absorption through the skin.

The order does not amount to an unrestricted approval of bemotrizinol in every type of sunscreen. It defines conditions for concentration, permitted combinations with other active ingredients, and dosage forms. Bemotrizinol may be used in oils, lotions, creams, gels, butters, pastes, ointments, sticks, and certain sprays. For spray products, the order permits pump sprays without a propellant and systems in which the propellant is isolated from the product formulation, such as bag-on-valve packaging.

Notably, FDA did not include powder sunscreens or conventional aerosol products in which the formulation is directly combined with a propellant. The agency found that the submitted data did not support a powder dosage form and were insufficient to support the propellant-mixed aerosol formulation evaluated. This does not establish that every product in those categories is unsafe. It means the evidence before FDA was not sufficient to support those specific conditions of use for bemotrizinol.

Why Does FDA’s Decision to Add Bemotrizinol to the Sunscreen Monograph Matter to Industry?

The immediate effect is a new formulation option for the U.S. sunscreen market. Bemotrizinol may allow manufacturers to develop products with broad-spectrum performance and formulation characteristics that were previously available in other markets but not under the U.S. OTC monograph.

The broader significance is the regulatory pathway itself. Bemotrizinol is the first new active ingredient added to an OTC monograph through the administrative-order process established by the CARES Act. Its addition shows that the OTC monograph order request process can create a pathway for innovation when a request is supported by a sufficiently robust evidence package.

For companies developing or evaluating sunscreen products, several lessons stand out:

• 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. Changes in delivery system can change particle or droplet size, inhalation potential, deposition, systemic uptake, and other exposure characteristics.
• International experience can inform, but does not replace, a U.S. evidence strategy. History of use and foreign-market data may be important lines of evidence, but they 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, data gaps, and regulatory requirements are best evaluated during development rather than 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.

The 18-month statutory exclusivity described in FDA’s order also creates near-term commercial considerations for ingredient sourcing, licensing, product-development timing, and market-entry strategy.

The Powder Sunscreen Question: Exposure is Essential to the Analysis

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 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 two different approaches. A hazard-minimization approach focused on whether particles smaller than a specified size were present. A human health risk assessment approach evaluated measured exposure in the context of toxicological thresholds and product-specific factors such as particle agglomeration and coating characteristics.

This distinction is consequential. Particle size may help identify the potential for inhalation, but it does not by itself quantify the dose a consumer may receive or determine the likelihood of an adverse health effect. A scientifically robust assessment connects the hazard information to real-world exposure, dose-response evidence, formulation properties, use conditions, and relevant populations.

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.

How RHP Risk Management Supports Sunscreen and Personal Care Product 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:

• product-specific exposure testing and exposure modeling;
• laboratory and field study design;
• inhalation exposure characterization for powders and sprays;
• toxicological review, hazard characterization, and dose-response analysis;
• weight-of-evidence and systematic review;
• assessment of formulation changes and alternative delivery systems;
• product stewardship and regulatory science strategy;
• evaluation of data gaps and development of targeted testing programs; and
• clear risk characterization and communication for regulators, customers, internal decision-makers, and other stakeholders.

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.

To discuss a sunscreen or consumer product safety question, contact RHP Risk Management by calling (866) 481-8188.