More effective sunscreen ingredients available overseas but not in the US: Shots

In Europe, sunscreens are often made with ingredients that better protect against UVA rays.

Iana Kunitsa/Getty Images

hide caption

toggle caption

Iana Kunitsa/Getty Images

In Europe, sunscreens are often made with ingredients that better protect against UVA rays.

Iana Kunitsa/Getty Images

When dermatologist Adewole “Ade” Adamson sees people spraying sunscreen like cologne by the pool where he lives in Austin, Texas, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.”

The question is not just whether people are using enough sunscreen, but what ingredients it contains.

In countries like Japan, South Korea, and France, sunscreens include newer chemical filters, some of which have been found to provide broader protection against UV rays than those used in the United States.

The Food and Drug Administration’s ability to approve such ingredients is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified as drugs, rather than cosmetics as is the case in much of the world.

So Americans are unlikely to get these other sunscreens — which better block UVA rays that can cause skin cancer and lead to wrinkles — in time for this summer, or even next.

Sunscreen makers say U.S. approval standards are unfair because companies including BASF Corp. and L’Oréal, which manufactures the new sunscreen chemicals, submitted safety data on sunscreen chemicals to European Union authorities about 20 years ago.

Steven Goldberg, a retired BASF vice president, said companies are wary of the FDA process because of its cost and their fear that additional animal testing could trigger a consumer backlash in the European Union, which prohibits animal testing for cosmetics, including sunscreen.

The companies are calling on Congress to change testing requirements before taking steps to enter the U.S. market.

In a rare example of bipartisanship last summer, Sen. Mike Lee, R-Utah, thanked Rep. Alexandria Ocasio-Cortez, D.N.Y., for urging the FDA to expedite approval of new, more effective sunscreen ingredients. A bipartisan bill is currently pending in the House that would require the FDA to allow animal-free testing.

“This goes back to the fact that sunscreens are classified as over-the-counter medications,” said Carl D’Ruiz, a senior executive at DSM-Firmenich, a Swiss manufacturer of sunscreen chemicals. “It’s really about giving the American consumer something that the rest of the world has. People don’t die from using sunscreen. They die from melanoma.”

A safer sunscreen? Misinformation in the sunscreen debate

Every hour, at least two people die from skin cancer in the United States. Skin cancer is the most common cancer in America, and 6.1 million adults are treated for basal and squamous cell carcinomas each year, according to the Centers for Disease Control and Prevention. The nation’s second most common cancer, breast cancer, is diagnosed about 300,000 times a year, although it is far more deadly.

Although skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer before age 70. The disease costs the health care system $8.9 billion a year, according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States more than doubled between 2002 and 2011, while the average annual cost of all other cancers increased by only 25%.

And unlike many other cancers, most forms of skin cancer can be largely prevented by using sunscreens and taking other precautions.

But a heavy dose of misinformation has permeated the sunscreen debate, and some people are questioning the safety of common sunscreen ingredients (such as avobenzone, homosalate, octisalate, and octocrylene) in the United States. -United States, which they ridicule by calling them “chemical” sunscreens.

These sunscreen opponents prefer “physical” or “mineral” sunscreens, such as zinc oxide, even though all sunscreen ingredients are chemicals.

“It’s an artificial categorization,” said E. Dennis Bashaw, a retired FDA official who headed the agency’s clinical pharmacology division that studies sunscreens.

Yet these concerns were fueled in part by the FDA itself after it released a study that found some sunscreen ingredients had been found in trace amounts in human blood. When the FDA said in 2019, and then again two years later, that old sunscreen ingredients needed to be studied further to see if they were safe, sunscreen opponents saw an opening, said Nadim Shaath, president of Alpha Research & Development, which imports chemicals. used in cosmetics.

“That’s why we have extremist groups and people who are not well informed who think that something that gets into the skin is the end of the world,” Shaath said. “Everything you put on your skin or eat is absorbed.”

Ingredients that work best to block UVA rays

Adamson, the Austin dermatologist, said some sunscreen ingredients already available in the United States have been used for 30 years without any population-level evidence that they have harmed anyone.

“The problem for me is not the safety of the sunscreens we have,” he said. “Some chemical sunscreens are not as broad spectrum as they could be, meaning they also do not block UVA. This could be mitigated if the FDA approves new ingredients.”

Ultraviolet radiation falls between x-rays and visible light on the electromagnetic spectrum. Most of the UV rays that people come into contact with are UVA rays which can penetrate the middle layer of the skin and cause up to 90% of skin aging, along with a smaller amount of UVB rays which cause Sun burn.

The sun protection factor, or SPF, listed on American sunscreen bottles only indicates a sunscreen’s ability to block UVB rays. Although U.S. sunscreens labeled “broad spectrum” should, in theory, block UVA rays, some studies have shown that they do not meet the European Union’s higher standards for UVA blocking.

“It appears that a number of these newer chemicals have a better safety profile in addition to better UVA protection,” said David Andrews, deputy director of the Environmental Working Group, a nonprofit organization. non-profit that studies ingredients in consumer products. “We have asked the FDA to consider allowing market access.”

The FDA defends its review process and its call to test sunscreens sold in U.S. stores as a way to ensure the safety of products that many people use daily, rather than a few times a year at the beach.

“Many Americans today rely on sunscreen as a key part of their skin cancer prevention strategy, making good evidence of the safety and effectiveness of these products essential for public health,” wrote Cherie Duvall-Jones, an FDA spokesperson, in an email.

The path to approval of a foreign ingredient: bemotrizinol

D’Ruiz’s company, DSM-Firmenich, is the only one currently seeking U.S. approval for a new over-the-counter sunscreen ingredient. The company has spent the past 20 years trying to gain approval for bemotrizinol, a process that D’Ruiz said cost $18 million and progressed fitfully, despite attempts by Congress in 2014 and 2020 to accelerate requests for new UV filters.

Bemotrizinol is the base ingredient in almost all European and Asian sunscreens, including those from the South Korean brand Beauty of Joseon and Bioré, a Japanese brand.

D’Ruiz said bemotrizinol could gain FDA approval by the end of 2025. If that were the case, he said, bemotrizinol would be the most approved sunscreen ingredient and the safest on the market, even surpassing the safety profiles of zinc oxide and titanium dioxide.

As Congress and the FDA debate the issue, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the risk of counterfeit products.

“The sunscreen issue made people realize that you can be dangerous if you’re too slow,” said Alex Tabarrok, an economics professor at George Mason University. “The FDA is just incredibly slow. They’ve literally been studying this for 40 years. Congress ordered them to do this, and they still haven’t done it.”

KFF Health News is a national newsroom that produces in-depth journalism on health issues and is one of the major operating programs of KFF.