One Chemist, Three Companies, One Molecule: How Bemotrizinol Finally Cleared the FDA

Carl D'Ruiz has worked on the same molecule since the late 1990s, when he joined Ciba Specialty Chemicals and began assembling the dossier for a UV filter called bemotrizinol. He was still working on it when BASF bought Ciba in 2008, and he was still working on it seven years ago when he joined dsm-firmenich. On June 9, 2026, the FDA finally granted it clearance, making it the first new sunscreen active ingredient approved in the United States since 1999.

The approval itself arrived through an unusual door. DSM Nutritional Products filed what the agency calls a Tier 1 OTC Monograph Order Request in September 2024, and the FDA issued a proposed order in December 2025 before finalizing Order OTC000039 this summer, adding bemotrizinol to monograph M020. According to a client alert from Venable, this marks the first ingredient ever cleared through the administrative-order process Congress created in the 2020 CARES Act, replacing the slower notice-and-comment rulemaking that had stalled sunscreen reviews for decades.

That procedural shortcut mattered because the alternative route had failed for a quarter century. D'Ruiz originally filed under the FDA's Time and Extent Application process in 2005, one of eight sunscreen filters that got stuck there. Congress passed the Sunscreen Innovation Act in 2014 specifically to force the FDA to act on the backlog, and the agency's subsequent 2015 review found that all eight ingredients still lacked sufficient safety data for a GRASE finding. Bemotrizinol is the only one of the eight to emerge with a final order. The other seven, including amiloxate, enzacamene, drometrizole trisiloxane and octyl triazone, remain stuck, some without any sponsor contact since 2003.

The caution traces partly to the FDA's own findings about the sunscreen filters already on the market. Maximal-use studies the agency published in 2019 and 2020 showed that oxybenzone, avobenzone, octocrylene, homosalate, octinoxate and octisalate are absorbed into the bloodstream above the agency's own safety threshold, prompting a 2019 proposed rule concluding that twelve of the sixteen marketed filters lack adequate GRASE data. A new chemical filter, even one with a long record of use abroad, was reviewed inside that climate of institutional wariness.

Bemotrizinol itself is not new anywhere except the United States. Formulators in Europe and Asia have used it for more than two decades, and the FDA's order caps its concentration at 6 percent, below the 10 percent ceiling permitted in the EU, a gap that will shape how closely American reformulations can match the European originals sold under the same name.

The clearance also surfaces a branding quirk built into the ingredient's corporate history. BASF, which inherited Ciba's original patents, sells the molecule as Tinosorb S. dsm-firmenich, which held the US sponsorship through the monograph filing, will bring it to market as PARSOL Shield, and that filing earns dsm-firmenich an 18-month period of marketing exclusivity in the US despite BASF's older claim to the chemistry. Both companies issued separate statements celebrating the same FDA order, a split that formulators licensing the ingredient domestically will need to navigate.

D'Ruiz has also become the industry's face in a parallel fight in Washington. He testified before the House Energy and Commerce Health Subcommittee in April 2025, arguing that outdated US testing standards were denying Americans access to filters used safely abroad for decades, and he cited figures on skin cancer, framed by the subcommittee as the fastest-growing cancer in the country, with 6.1 million adults treated annually at a cost of roughly 9 billion dollars. Scott Faber testified the same day with a more skeptical view of loosening monograph standards, and the Senate advanced its own OTC Reform Bill with sunscreen provisions in mid-2025, meaning bemotrizinol's approval is already being cited in industry's broader lobbying push for further changes to the monograph system.

Formulations containing bemotrizinol become legally marketable in the United States on August 9, 2026, and dsm-firmenich has said PARSOL Shield-branded products will begin appearing in oils, lotions, creams, gels, sticks and sprays this summer. For D'Ruiz, the molecule now carries three corporate names across three employers and one FDA order number.