New sunscreen ingredient wins FDA approval after 25 years of delay

The long wait for bemotrizinol in U.S. sunscreens was driven far more by how the FDA regulates sunscreen than by any safety concern about the ingredient itself—and understanding that distinction is the key to making sense of the 25‑year delay.

Key Points

Bemotrizinol is a broad‑spectrum, photostable UV filter with a decades‑long safety record abroad; the FDA now classifies it as “generally recognized as safe and effective” (GRASE) for people 6 months and older.^[4]
The U.S. treated sunscreens as over‑the‑counter drugs, not cosmetics, forcing new filters like bemotrizinol through a slow, monograph‑style drug review that effectively stalled innovation for more than 20 years.
Congress’ 2020 CARES Act created a streamlined “administrative order” pathway; bemotrizinol was the first sunscreen filter to go through this modern process and was finalized within seven months of the FDA’s proposed order.^[4]
The ingredient’s long international use and extensive safety package mean the delay reflects regulatory inertia and resource constraints, not a hidden safety red flag.^[4]

What bemotrizinol is and why dermatologists wanted it

Bemotrizinol—also labeled bis‑ethylhexyloxyphenol methoxyphenyl triazine, and sold internationally as Tinosorb S—is a modern organic (chemical) UV filter designed to solve several weaknesses of older U.S. filters.^[1] It absorbs both UVA and UVB radiation, giving true broad‑spectrum coverage in a single molecule rather than relying on a patchwork of ingredients.^[1]^[3]^[4] Unlike some legacy filters that degrade quickly in sunlight, bemotrizinol is highly photostable and can also help stabilize other filters in a formula.^[1]^[4]^[5]

From a user’s standpoint, dermatologists highlight three practical advantages. First, it provides stronger, more durable UVA protection than many existing U.S. filters, important because UVA drives both photoaging and a substantial portion of skin cancer risk.^[2]^[4] Second, its relatively large molecular size means it penetrates the skin poorly, resulting in low systemic absorption and a safety profile regulators are comfortable with even in infants over six months.^[4] Third, it has a cosmetically elegant feel and can be combined with mineral filters like zinc oxide without producing the opaque “white cast” that discourages consistent daily use.^[4]

How U.S. sunscreen regulation created a 25‑year bottleneck

To understand the delay, you have to separate the question “Is bemotrizinol safe?” from “Why was the pathway so slow?” In the United States, sunscreen active ingredients are regulated as over‑the‑counter (OTC) drugs, not cosmetics. That single classification decision meant any new UV filter had to clear a drug‑style safety and effectiveness review similar in structure—though not in depth—to prescription medications.^[1]

For decades, this review ran through the OTC “monograph” system, which was never designed for nimble updates. Sponsors submitted a “Time and Extent Application” (TEA) to show an ingredient had been widely used abroad, then waited for the agency to issue or revise a detailed monograph specifying allowable concentrations, labeling, and testing requirements. In practice, those TEAs piled up while the FDA, with limited staff and statutory tools, struggled to move them to a conclusion.^[5]

Bemotrizinol fell straight into this structural bottleneck. Its TEA lingered for years while the agency juggled other priorities and publicly signaled that it lacked both the resources and, at times, sufficient data to complete a full GRASE (generally recognized as safe and effective) determination under the old framework.^[5] During the same period, Europe and other markets—treating sunscreens as cosmetics—approved multiple modern filters, so American consumers watched an entire generation of UV technology pass them by.^[2]

The CARES Act and the new “administrative order” path

The logjam only broke when Congress rewired the machinery. In 2020, as part of broader COVID‑era legislation, lawmakers passed the CARES Act, which quietly transformed how OTC drugs—including sunscreens—are updated. Instead of rewriting monographs through full rulemaking, the FDA can now revise them via “administrative orders” under section 505G of the Food, Drug, and Cosmetic Act.^[4]

Under this system, a manufacturer can submit an OTC Monograph Order Request (OMOR) with the safety, pharmacokinetic, and effectiveness data needed for a modern GRASE review. The FDA then evaluates the package, issues a proposed order if the evidence supports it, opens a short public comment period (typically 45 days), and finally issues a binding order that amends the sunscreen monograph.^[4] The CARES Act did not lower the scientific bar for GRASE determinations; it simply streamlined the process from a procedural standpoint.

Bemotrizinol became the test case for this modernized model. DSM Nutritional Products submitted an OMOR in September 2024. The FDA issued a proposed order to add bemotrizinol—at concentrations up to 6%—as a sunscreen active ingredient on December 12, 2025, and invited public comment through late January.^[4] After reviewing the comments, the agency finalized the order on June 9, 2026, making bemotrizinol the first new active added to the OTC sunscreen monograph since the late 1990s and the first ever approved through the new CARES pathway.^[4]^[1]

What the FDA actually decided about safety

The final order and accompanying press materials are explicit on the safety question. The agency states that bemotrizinol “provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body” and that it is GRASE for adults and children 6 months and older at concentrations up to 6%.^[4]^[1] In other words, by the time it gave the green light, the FDA was satisfied on both efficacy and margin of safety.

That conclusion rests on a data set that is unusually robust for an OTC sunscreen ingredient. According to industry and watchdog summaries, the bemotrizinol application included a two‑year animal carcinogenicity study, a multigenerational reproductive study, human skin‑irritation and repeat‑application trials, and pharmacokinetic work showing that blood levels—when detectable at all—rarely exceeded the agency’s 0.5 ng/mL threshold for additional concern. Regulators also had the benefit of more than 25 years of international market experience without major safety signals.^[1]^[4]

So why did it really take so long?

When you put the pieces together, the narrative looks less like a mystery about a risky chemical and more like a case study in regulatory inertia. Several elements reinforced each other:

First, the monograph system was simply not built for rapid incorporation of new science. Even enthusiastic FDA staff had limited statutory room to maneuver; revising an OTC monograph required labor‑intensive rulemaking that regularly took years. Second, sunscreens were competing for agency attention with prescription drugs, vaccines, and other high‑stakes priorities, making it easy for “only” a preventive product to slide down the queue.

Third, the early bemotrizinol dossier arrived during a period when the FDA was reevaluating its entire approach to sunscreen safety, particularly around systemic absorption of legacy filters. The agency asked for additional data on several ingredients, which, while reasonable from a public‑health standpoint, further stretched timelines.^[5] All of this unfolded against a backdrop of modest congressional funding for OTC modernization—until the CARES Act finally provided both a new structure and political impetus to clear the backlog.

What this means for consumers and for future sunscreen filters

For consumers, the arrival of bemotrizinol means that U.S. shelves will finally begin to resemble those in Europe and Asia in terms of UVA protection and product aesthetics. The FDA’s order took effect immediately upon issuance, but manufacturers still need to develop, stability‑test, and scale up new formulas, so experts expect broad availability over the subsequent year or two.^[1]^[5] Initial products will use DSM‑Firmenich’s branded version, Parsol Shield, under an 18‑month exclusivity window before other companies can incorporate the filter.^[3]^[4]^[5]

From a public‑health perspective, the more consequential change may be what bemotrizinol’s approval signals about the future. It demonstrates that the OMOR/administrative‑order framework can process a modern UV filter in under a year once the data are assembled. That precedent lowers the barrier for other advanced filters—such as bisoctrizole or TDSA—that are already widely used abroad and supported by respectable safety records.^[1]

The structural lesson is broader still. When regulators finally act on a long‑pending ingredient, it is tempting to infer that they have “discovered” something new about its safety. The bemotrizinol story shows how misleading that assumption can be. Often, as here, the science has been relatively stable for years; what changes is the machinery for turning that science into legally usable tools.