Why you should care about first new FDA-approved sunscreen ingredient in 20 years

Health

FDA has approved the first new sunscreen ingredient in 20 years

HMS dermatology professor Hillary Tsibris explains why you should care

Alvin Powell

Harvard Staff Writer

July 20, 2026

8 min read

The Food and Drug Administration in June approved the first new general sunscreen ingredient in 20 years: bemotrizinol, or BEMT. Dermatologists and oncologists applauded the move because it provides broader and longer-lasting protection than current sunscreens on the U.S. market and comes at a time when melanoma rates are on the rise.

In this edited conversation, the Gazette spoke with Hillary Tsibris, Harvard Medical School assistant professor of dermatology at Brigham and Women’s Hospital and director of melanoma dermatology at the Dana-Farber Cancer Institute. Tsibris said BEMT has been used in Europe for decades but held up by the U.S. regulatory process.

How is it that this new sunscreen chemical is the first in decades that the FDA has approved?

With the exception of a few very specific formulations that were approved in a limited capacity in 2006, this is the first general sunscreen ingredient, sunscreen filter, that the U.S. has approved in more than two decades.

The biggest holdup has been that the U.S. regulates sunscreen filters as over-the-counter drugs. That means that they are subject to strict, pharmaceutical-style testing and trials prior to approval.

Along with that lengthy review, there’s been a backlog in the approval process. That has led the U.S. to be far behind European and international counterparts that regulate sunscreen filters differently, as cosmetics in Europe or as quasi-drugs in Asia.

How did BEMT finally get through the process?

There was a big change in November of 2025. There was a bipartisan law passed called the SAFE Sunscreen Standards Act. It modernized the FDA approval and review process for sunscreen ingredients.

Now we aren’t just restricted to traditional clinical trials for data. We can use real-world data. That has allowed us to have clearer, more flexible standards and has streamlined the process for us to review the available sunscreen filters. I think that new process is better, more flexible, and allows faster approvals.

Hopefully it is going to allow us to access these global ingredients and more updated, innovative, and better sunscreen filters.

BEMT is in Europe, but are there more promising sunscreen chemicals in Europe and elsewhere?

There are more out there. BEMT itself is unique in several ways, but yes, there are other European filters that hopefully we’ll also see approved in the U.S.

BEMT is also called Tinosorb S, and there’s another filter called Tinosorb M, which is bisoctrizole. That’s another one we may see approved in the U.S.

There’s also one called drometrizole — its other name is Mexoryl XL — hopefully that’s another that we’ll see come to the U.S. at some point soon. These filters are available in Europe, in Asia, but have not been approved for U.S. manufacturing.

Let’s talk about BEMT specifically. What are its advantages?

One is that it offers broad spectrum protection. That means it protects against both ultraviolet A and ultraviolet B.

Ultraviolet rays are split into UVB, which is what causes sunburn and also leads to the development of skin cancer, and UVA. UVA rays don’t cause sunburn, but they contribute to skin aging and also skin cancer development. Most of the filters that are approved in the U.S. protect against UVB, but not UVA.

BEMT protects against both and that broad-spectrum protection makes it unique. It’s also photostable, which means it doesn’t lose its effectiveness when it’s exposed to light.

The only chemical UVA filter that was approved in the U.S. prior to this was avobenzone. Avobenzone is not photostable, so when it’s exposed to light it loses its effectiveness over time. It has to be paired with other ingredients that stop that from happening.

BEMT also doesn’t have a white cast. The two physical or mineral sunscreen filters that are approved in the U.S., zinc oxide and titanium dioxide, have a white cast when they’re applied to the skin. People don’t like that and BEMT doesn’t have that, so it looks nice and it feels nice on the skin.

The other thing about BEMT is that in studies done to date, it has really low absorption. One of the concerns out there about chemical sunscreen filters is that they can be absorbed through the skin into the bloodstream. BEMT has extremely low absorption. It sits on the skin surface and really doesn’t significantly penetrate into the bloodstream.

So, are this new chemical’s characteristics pretty much all we’re looking for in a sunscreen? Are there other sunscreens in Europe or Asia that actually do more?

It’s pretty good. I think water resistance is the other thing that you’re potentially looking for in the formulation, but this has almost everything that we’re looking for.

I read that this is not going to be available right away.

They can start manufacturing it on Aug. 9, and I believe there’s an 18-month period of exclusivity, where it will be sold to manufacturers under the brand name Parsol Shield.

Even the best sunscreen is only good if people use it. Do we know what proportion of the public actually uses sunscreen?

The percentage of the U.S. population that uses sunscreen has been increasing over time. Recent figures put it around 79 percent, so it’s pretty high. That is not a measure of whether people are using it consistently or appropriately, and I think that is a more challenging question to study and answer.

Are there any estimates of that?

No, but it’s important to think about sun protection as a combination of different things.

It’s not just sunscreen use. It can include staying out of the direct sun during the peak hours of UV exposure, between 10 a.m. and 4 p.m. It can include staying in the shade. Sun-protective clothing is great, like a broad-brimmed hat and UPF clothing — shirts and other clothing items that have sun protection built into the fabric.

I tell my patients that they can do a combination of these things, so a hat and a UPF protective shirt and then sunscreen on the skin that’s exposed.

Does the advice change for people who work outside?

That’s where the UPF protective clothing and hats play an even more important role. It’s much easier to have a broad-brimmed hat and a lightweight, UV-protective shirt than having to constantly reapply or to worry about how sunscreen might interfere with your dexterity or your grip.

I tell my patients that ideally, on a daily basis, you’re doing your head and neck and the back of your hands.

Then, if you’re going to be outside, making sure that you’re protecting the rest of the skin with reapplication every two to three hours. Or, if you sweat or swim, that is when you should be mindful of reapplication. But you don’t have to reapply a UV protective shirt, you just keep it on.

What about kids and older adults? Do the guidelines change?

BEMT was approved for use for children 6 months and older. For infants that are under 6 months, we recommend keeping them out of the sun or using sun-protective clothing rather than sunscreen.

Over the age of 6 months, I’d still advocate for sun-protective clothes and avoiding direct sun exposure as much as possible and using approved sunscreens on exposed areas of their skin. My recommendations for older adults are the same as they are for other adults.

What’s the recent trend for skin cancers?

Rates of melanoma have been increasing, but this is a complicated topic, because that includes rates of in situ melanoma that have been rising more quickly than invasive melanoma. There are a number of factors that may be contributing to that, but overall rates of melanoma have been increasing, somewhere in the 5 percent to 6 percent range in 2025.

That seems like a pretty high rate. Is that the bill coming due from decades ago, when people didn’t use sunscreen nearly as much as today?

I’m speaking specifically about melanoma, and that includes both invasive and in situ melanomas.

It’s a combination of things. One, there were changes in trends for UV exposure. If you look back at the ’50s and ’60s, getting more sun exposure, becoming tan, was more fashionable. We saw the introduction of indoor tanning starting in the 1980s.

Then, I think there is a separate question of whether we are diagnosing melanoma at higher rates than has previously been the case because we are clinically looking more or because of changes in how pathologists read those biopsies.

It’s summertime. What do you tell your patients about enjoying outdoor time in the sun safely?

I tell my patients that I want them to do the things they love to do outside, but I want them to be careful while they do it. I love nothing better, myself, than going outside.