Europe Got This Sunscreen in 2000. America Just Caught Up.
Europeans have used bemotrizinol since 2000. It took a reform hidden in the 2020 COVID relief bill for Americans to get it, and a decade of advocacy before that.
Why the wait
This week the FDA cleared a new sunscreen ingredient called bemotrizinol for sale in the United States. It is the first new sunscreen filter the agency has added since the late 1990s. Products using it are expected to reach U.S. stores later this year.
If you live in Europe, Asia, or Australia, none of this is news. People there have been putting bemotrizinol on their kids for about 25 years. It is a well-studied broad-spectrum filter, meaning it blocks both UVA and UVB rays. So the real question is why a country with some of the best science in the world was so behind on something as basic as sunscreen.
The answer lies in how the U.S. regulates sunscreen.
The regulatory logjam
In the United States, the active ingredients allowed in sunscreen are set by something called a monograph. Think of it as the official rulebook of which filters are approved and at what strength. For decades, changing that rulebook required a slow formal process called notice-and-comment rule-making. It could take many years to move a single ingredient through it.
The FDA had not approved a new sunscreen filter since 1999. By the 2010s, the U.S. had roughly 10 approved UV filters while Europe had more than 30. That gap mattered most for UVA protection, the deeper rays tied to skin aging and skin cancer, where many older American sunscreens were weaker.
Congress tried to fix this once before. In 2014 it passed the Sunscreen Innovation Act, pushed hard by dermatologists, skin-cancer groups, and sunscreen makers working together as the Public Access to Sun Screens Coalition. The bill passed both chambers unanimously. And then it did almost nothing, because it left the broken approval framework in place. The FDA responded by asking for more safety and skin-absorption data, and the backlog stayed frozen. A law that everyone agreed with failed because it did not change the machinery underneath.
What actually fixed it
The fix that worked arrived in an unlikely place: the 2020 CARES Act, the giant COVID relief bill. Tucked inside it was a long-pending, bipartisan reform of how the FDA reviews over-the-counter drugs, sponsored in the Senate by Bob Casey and Johnny Isakson and carried in the House by the leaders of the Energy and Commerce Committee.
It did two practical things. It replaced the slow rule-making process with a faster administrative order process, so the FDA could add or update an ingredient by order instead of a years-long rule. And it created industry-paid user fees that gave the agency dedicated staff and money to actually do the reviews.
It rode a pandemic bill for practical reasons. It was ready, it was bipartisan, the user fees made it look like it paid for itself, and it gave the FDA faster authority over products like hand sanitizer, which fit the moment. The muscle behind the text came mostly from the over-the-counter drug industry’s trade group and the FDA, which had negotiated the deal years earlier. Public-health and dermatology groups supplied the urgency and the headlines.
Bemotrizinol is the first sunscreen filter to go all the way through that new path. Its maker, DSM-Firmenich, filed its request in 2024, and the FDA finalized the approval this week, up to a 6% concentration, for adults and children 6 months and older.
What the new ingredient actually does
Bemotrizinol earns its place for a few concrete reasons. It gives strong protection in the UVA range where older U.S. filters lag. It is also unusually photostable, which is the useful part most people never hear about. Some common filters break down in sunlight and lose strength within a couple of hours. Bemotrizinol holds up, and it can help keep other filters in the bottle from breaking down too.
It also barely soaks into the skin, rarely causes irritation, and showed no estrogen-like activity in lab testing, which has been a worry with some older chemical filters. And it tends to feel lighter and leaves less of the white cast that mineral sunscreens can. That sounds like a cosmetic detail, but it isn’t. The sunscreen that protects you is the one you are willing to put on every day.
The credit-claiming
The political framing arrived fast. The Department of Health and Human Services tied the approval to the administration’s Make America Healthy Again agenda, with Secretary Robert F. Kennedy Jr. presenting it as the government finally bringing a new sunscreen to market.
The timeline doesn’t support that. The law that made this possible passed in 2020. The company’s application came in 2024. The review was done by career FDA scientists working through a process Congress built years earlier. This crossed more than one administration, and it was driven for over a decade by advocates and industry, not by any single White House.
There is a useful lesson buried in that history about how change actually happens. Ordinary people did help force this. Melanoma survivors, dermatologists, and patient groups kept a dull regulatory problem in front of Congress year after year until it moved. That kind of steady, organized pressure works better than any single voice. It is also worth knowing that these campaigns often blend patient advocacy with industry money, so the smart move is always to ask who is funding the message.
Sunscreen denialism
The same online world that rewards health populism is now full of videos telling people that sunscreen is the real danger. One reel asking whether SPF even matters has about 3 million views. The claims range from “SPF doesn’t work” to “the sun isn’t the enemy, sunscreen is.”
This is happening at the worst possible time, just as the U.S. finally gets a better-tested filter. Skin cancer is the most common cancer in the country, and about 1 in 5 Americans will develop it. Both UVA and UVB rays raise that risk. Skipping sunscreen is the real gamble. And a lot of the doubt being sold online runs right next to ads for supplements and “natural” routines, because there is money in making you afraid of a cheap product that helps prevent cancer.
Bottom line
A new sunscreen ingredient is good news. The better story is the system around it. For 25 years the obstacle was a regulatory process with no working way to approve safe, widely used ingredients. It took an industry user-fee deal embedded in a pandemic bill to fix that.