The last time a new sunscreen active ingredient — you know, the good stuff that protects skin from the sun’s aging and cancer-causing rays — was approved in the United States, Britney Spears and Justin Timberlake were dating, “Believe” by Cher was top of the charts, and The Sopranos had just debuted on HBO.
Before you cry a river, some good news: In June, four representatives from Congress introduced the bipartisan bill, the SAFE Sunscreen Standards Act, to overhaul regulations many feel are more dated than the above pop culture references. If passed, the act would introduce more modern evaluation methods, including real-world studies and alternatives to animal testing, putting us better in line with current global standards.
“This is a big deal,” says Carl D’Ruiz, the head of science advocacy and business development at DSM-Firmenich in North America, which manufactures sunscreen ingredients, among other beauty products. “The Food and Drug Administration (FDA) has been under fire from Congress for not having been able to add a new [sunscreen] ingredient since 1999. At least it gives you a fighting chance to bring innovation that hasn’t been introduced to the US that’s available in other countries.”
The Food and Drug Administration (FDA) has been under fire from Congress for not having been able to add a new [sunscreen] ingredient since 1999.
Carl D’Ruiz, head of science advocacy and business development at DSM-Firmenich
Why do US sunscreens fall behind?
While in Asia and Europe, sunscreens are considered cosmetic, here they are classified as drugs and regulated by the FDA, which means any new filter needs to undergo a full approval process to be considered GRASE or generally recognized as safe and effective.
That means an incredible amount of testing. From human clinical studies (these are called maximum usage trials, basically putting swathes of sunscreen on to mimic worst-case exposure; something no other country uses to test sunscreen) to animal testing (the latter, which most brands don’t want to do, for good reason). The process can take years and cost millions of dollars.
Complicating the matter? It’s up to the sunscreen brands to pay for this testing themselves. D’Ruiz’s company is close to getting the ingredient PARSOL Shield (aka bemotrizinol) across the finish line of FDA approvals. He estimates they’ve spent $9 million since 2018 alone. To be clear, PARSOL Shield is a veteran chemical filter (chemical filters absorb UV rays and convert them to heat) that’s been in use in formulas around the world since 2001.
In an extra special gut punch, once approved, D’Ruiz’s company only gets exclusivity on using PARSOL Shield for 18 months before other brands can tap it for their formulas. “That’s one of many issues the industry has with this testing,” says Becky Kamowitz, executive director of the Skin Cancer Foundation. “If one manufacturer goes ahead and pays for that testing, why would another manufacturer also pay for it? It would fall to the larger companies to do this, and the larger companies don’t want to bear that burden to have smaller companies profit off of their testing.”
The Skin Cancer Foundation has drafted a letter of support for the SAFE Sunscreen Standards Act for people to sign. The act is currently in limbo: It has been referred to the House Committee on Energy and Commerce, but hasn’t been ratified and will go back in front of them in September. However, a companion bill in the Senate was passed unanimously on July 30.
Before you clean out your current sunscreen supply, the approved filters in the US are not less effective than others on the market.
When will we get better sunscreen?
But time is ticking. Michael Werner, senior policy advisor to the Public Access to Sunscreens (PASS) Coalition, says, “September is a critical month for the SAFE Sunscreen Act because it is tied to the reauthorization of the Over-the-Counter Monograph User Fee Act (OMUFA), which is a must-pass bill as the program will expire Sept 30. The Senate and House versions of the bill will need to be reconciled and passed in both chambers to become law.”
It’s high stakes — even everybody’s favorite Congressperson, Alexandria Ocasio-Cortez, has weighed in on the issue. Back in 2023, she went live on Instagram with Dieux Skincare founder Charlotte Palermino discussing the issue. “US sunscreens are far behind the rest of the world,” adding, “We deserve better here in the US”
Especially because it’s the consumer who suffers. While about 30 to 40 filters are approved globally, only nine are commonly used in the US (two of which have been banned in Hawaii to protect the reefs). The FDA isn’t necessarily on board with all of these. In 2019, it asked for more data on 12 of the 16 filters currently approved for use in the US. Insert face-melting emoji here.
Are approved sunscreen filters less effective than others?
Before you clean out your current sunscreen supply, the approved filters in the US are not less effective than others on the market. “There’s a misconception that European Union-approved filters are automatically safer or that US filters are outdated,” says Dr. Caroline Robinson, Chicago-based dermatologist and founder of TONE. What we are lacking is newer filters, which Dr. Robinson says may improve cosmetic elegance and encourage more consistent use.
Outside of the SAFE Sunscreen Act, she hopes to see more inclusivity in future testing. “It’s important to recognize that sunscreen use among African Americans has historically been low, and only recently has it become more common,” she says. “Future decisions should be informed by research that includes all phototypes and addresses visible-light protection, not just UV, one of the many reasons I advocate for diversity in clinical trials.”
Think of the formulas you see all over TikTok, while we’re stuck with thicker, goopier formulas that leave white casts. Beauty of Joseon, a fave of AOC and all of Gen Z, even had to reformulate its viral sunscreen with filters approved in the US, to sell here.
“We’ve always said the best sunscreen is the one you are most likely to use,” agrees Kamowitz. “If Americans have more options for products, that would make them more likely to use these products. We know that these ingredients that are not available here might lead to a much better experience for people, if these products blend better, if they work better with their skin tone, that sort of thing.”
Especially in an era where skin cancer is the most common cancer in the US, instances of melanoma have doubled over the past 30 years. Gen Z on TikTok are shouting out the benefits of tanning beds, and some beauty brands are claiming that the sun isn’t poison; anything we can do to make people slather on their ‘screen is crucial.
In general, our experts agree that the best practice when you’re heading to your next outdoor park hang is daily use of a broad-spectrum SPF 30+, reapply every two hours outdoors, and combine with hats, shade, and protective clothing.
Britney Spears playlist optional.
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