The US is getting a new sunscreen ultraviolet (UV) filter for the first time in 30 years. On June 9, the US Food and Drug Administration issued a final order that adds bemotrizinol (BEMT) to its list of approved sunscreen ingredients and declares it to be generally recognized as safe and effective.
US Health and Human Services (HHS) secretary Robert F. Kennedy Jr. praised the result, saying in a press release that “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.” The FDA is a part of HHS.
BEMT had been languishing in the FDA’s approval process since 2002 despite the ingredient’s longstanding use in the rest of the world. It offers protection against a wider range of solar wavelengths, including both UVA and UVB radiation, than chemical UV filters previously approved for use in the US, such as octinoxate. It is also more stable than other US options, and its large molecular weight prevents it from being absorbed through skin and into the bloodstream.
The torturous timeline stems from the FDA’s regulation of UV filters as over-the-counter medications. That structure means an ingredient maker must pay for all the expensive efficacy and safety trials required of a new medicine, but without the profit margins normally enjoyed by pharmaceuticals. In most other regions, UV filters are regulated as cosmetic ingredients.
The ingredient supplier DSM-Firmenich has been sponsoring BEMT’s regulatory odyssey for many years at considerable expense, according to Carl D’Ruiz, an executive at the firm. D’Ruiz has been working on BEMT’s approval for 24 years: first at Ciba Specialty Chemicals, then at BASF after it acquired Ciba, and then at DSM-Firmenich since 2018.
The reward for DSM-Firmenich is an 18-month exclusivity period on BEMT sales, starting when the first consumer product is commercially available, which should happen by September, D’Ruiz says. Consumer-product makers can’t simply import sunscreens they already make for other regions, he says, because those typically use BEMT alongside UV filters that the FDA hasn’t approved. Most of the UV filters on the FDA’s list have been replaced outside the US by more-modern ingredients.
DSM-Firmenich heralded the US Food and Drug Administration’s approval of bemotrizinol at Supplier’s Day, a cosmetics and personal care chemistry conference, in May. The company markets the molecule as Parsol Shield. Credit:
Craig Bettenhausen/C&EN
DSM-Firmenich’s biggest BEMT competitor is BASF. Both firms heavily promoted the molecule in May at Supplier’s Day, a personal care science and ingredients conference put on each year by the New York Society of Cosmetic Chemists. Several booths from other companies promoted formulations featuring molecules from BASF or DSM-Firmenich. Some smaller chemical makers also make BEMT for the global market.
DSM-Firmenich will squeeze as much as it can out of its 18-month head start, D’Ruiz says. The firm plans to rigorously police both the exclusivity period and the purity details baked into the FDA’s approval, he says.
D’Ruiz says he and DSM-Firmenich are proud to be part of this public health victory, but the company has no immediate plans to seek FDA approval of other molecules used elsewhere in the world. The short exclusivity period makes a weak business case for any company to sponsor additional UV filters, he says.
That could change if the FDA is serious about the intentions it expressed in its notice about BEMT. Both Congress and multiple US presidents have repeatedly directed the agency to speed up its approval process for UV filters.
In the notice, Karen Murry, director of the FDA’s Office of Nonprescription Drugs, writes, “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.” But so far, the FDA doesn’t have any new UV filter molecule requests on its published docket.
