The Food and Drug Administration on Tuesday approved bemotrizinol for the U.S. market, the first new sunscreen ingredient American consumers have been allowed to buy in more than a quarter century. Europeans have had access to the same ingredient since 1999.
That gap, 26 years between European authorization and American approval, tells you nearly everything you need to know about the FDA's appetite for timely action on consumer products that don't carry billion-dollar pharmaceutical price tags.
The ingredient, which will initially be sold under the brand name Parsol Shield by DSM Nutritional Products, went through a streamlined review process that Congress had to create in 2020 because the agency's existing machinery couldn't get the job done. Bemotrizinol is the first ingredient to clear that new pathway. It won't be available to other manufacturers until an 18-month exclusivity period expires, CBS News reported.
The regulatory history here is worth laying out in full. European authorities authorized bemotrizinol in 1999. DSM first filed the ingredient with the FDA for review in 2005. The agency sat on it. In 2019, fourteen years after that initial filing, DSM began running a new round of studies the FDA had requested.
Congress finally intervened in 2020, authorizing a streamlined process specifically designed to update how the agency reviews safe nonprescription drug ingredients. Only then did the wheels begin to turn toward the approval announced this week.
Meanwhile, consumers in Japan, South Korea, and across Europe have been buying sunscreens with bemotrizinol for years. Carl D'Ruiz, DSM's senior regulatory and business development manager, told CBS News in 2024 that the ingredient is widely sold abroad under names like BEMT or Tinosorb S:
"Consumers are purchasing products with bemotrizinol when they go abroad, simply because they feel good, look good, and like the way it goes on the skin."
American travelers could buy the stuff overseas. They just couldn't buy it at home.
The agency stated that bemotrizinol met its standards for protecting against dangerous ultraviolet rays while causing little irritation or absorption into the skin. The FDA's own release declared the ingredient safe for adults and children six months and older.
Dr. Mike Davis, acting director of the FDA's drug center, framed the move as part of the agency's broader consumer mission:
"The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens."
That commitment, measured against the 20-year timeline from first filing to approval, reads more like an aspiration than a track record.
Health and Human Services Secretary Robert F. Kennedy Jr. praised the decision, calling it a step forward for innovation and consumer choice:
"Bemotrizinol has been used safely in Europe for decades, and FDA's action will increase competition and consumer confidence in sunscreen products."
Kennedy's emphasis on competition matters. For more than 25 years, American sunscreen manufacturers worked with a fixed, aging set of approved ingredients. No new entrants. No new formulations. No competitive pressure from better chemistry developed abroad.
CBS News chief medical correspondent Dr. Jon LaPook noted that bemotrizinol is not as easily broken down by the sun as currently available sunscreen ingredients, meaning the protection lasts longer. That's a practical difference for anyone who has reapplied sunscreen every hour at the beach and wondered why American products seem to wash off or fade faster than what they used on a trip to Barcelona.
The Environmental Working Group, which has long pushed the FDA to tighten sunscreen standards and allow new ingredients, welcomed the approval. David Andrews, a member of the group, put the delay in blunt terms:
"For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that."
When a consumer-advocacy group and the Trump administration's HHS secretary are saying essentially the same thing, that the FDA moved too slowly and American consumers paid the price, the critique is hard to dismiss.
Sunscreen regulation in the United States has moved at a pace that makes the DMV look nimble. The FDA banned misleading terms like "waterproof" in 2011, a change regulators themselves said was overdue. That same year, the agency required all sunscreens to filter out both UVA and UVB rays.
A decade later, in 2021, the FDA proposed additional measures, capping SPF numbers and requiring stronger UVA protection. Those proposals have not been completed.
So the pattern repeats: the agency identifies a problem, proposes a fix, and then lets the proposal languish while consumers keep buying products built on old science. Congress had to pass a law in 2020 just to force a workable review pathway for ingredients that other developed nations had already cleared.
Bemotrizinol's journey from 2005 filing to 2025 approval is not a story about rigorous science taking its necessary course. European regulators reviewed the same data and reached a conclusion in 1999. The FDA requested additional studies in 2019, studies that DSM then ran, and still needed Congress to build a new process before the agency could act.
DSM Nutritional Products plans to launch Parsol Shield later this year. After the 18-month exclusivity window closes, other manufacturers will be able to incorporate bemotrizinol into their own formulations. That should open the door to broader competition and, eventually, lower prices for consumers who want access to the same sunscreen chemistry the rest of the world already uses.
Whether the FDA's new streamlined pathway will produce faster results for other ingredients remains an open question. Bemotrizinol was the first to clear it. The test will be whether it was also the last to take two decades.
The agency says it's committed to giving Americans access to the best products. The calendar suggests otherwise. When it takes longer to approve a sunscreen ingredient than it took to put a man on the moon, the problem isn't science, it's bureaucracy.