European Sunscreen Roadblock on U.S. Beaches

Wall Street Journal (Subscription)

European Sunscreen Roadblock on U.S. Beaches 
By Sumathi Reddy

May 28, 2013

Karen Spear needed a passport to discover the sunscreens she wanted.

Ms. Spear, a school psychologist in New York who has suffered from past overexposure to the sun, said she was looking for extra protection for her skin. She finally got what she needed on trips to the Caribbean and Europe.

“I noticed that the consistency was better and nicer and not as expensive and gooey as the ones you buy in the States,” she said. “It is definitely much better than any of the sunscreens bought from the drugstores or cosmetic companies.”

After doing some research and consulting with her dermatologist, Ms. Spear learned of the key ingredient, Tinosorb S. About a year ago her son ordered online a European sunscreen, Avène Emulsion SPF 50+, not available in the United States. At $18, she found the price reasonable.

She is part of a group of attentive U.S. consumers savvy enough to find certain kinds of sunscreen despite regulations that make a purchase tougher than a trip to the corner pharmacy.

Eight sunscreen ingredient applications have been pending before the U.S. Food and Drug Administration for years—some for up to a decade—for products available in many overseas countries. The applications were filed through the federal TEA process (time and extent application), which allows the FDA to approve the ingredients if they have been used for at least five years abroad and have proved effective and safe. A spokeswoman for the FDA said federal law prevents the agency from disclosing information about applications under review.

New labels that first surfaced in December are appearing on U.S. sunscreens for the first time when people most notice them, as summer gears up. They’re designed to help consumers find “broad-spectrum” products that protect from both ultraviolet B and A rays. But some say U.S. brands are limited by the lack of long-range UVA filters, or sunscreen ingredients, not allowed by the federal government.

Henry Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a member of the American Academy of Dermatology, says multiple UVA filters still awaiting clearance in the U.S. have been used effectively outside the country for years.

“The U.S. is an island by itself on this one,” he said. “They’re available in Canada, available in Europe, available in Asia, available in Mexico, and available in South America.” 

The newly formed PASS Coalition, short for Public Access to Sunscreens, is urging the FDA to act on the eight pending applications for sunscreen ingredients. PASS members include chemical companies and others with applications before the FDA. 

”In the U.S. we only have three UVA filters that can extend the range of the UVA protection to the long range,” said Steven Wang, director of Dermatologic Surgery and Dermatology at Memorial Sloan-Kettering Cancer Center in New Jersey. Dr. Wang has had a consulting relationship with some companies that make sunscreen, including L’Oréal, OR.FR +1.75% the Paris-based cosmetic and beauty company, and is a member of PASS.

Both UVA and UVB rays contribute to skin cancer, but the damage caused by UVA rays is harder to measure. UVA filters block the rays from the sun that penetrate deep into the skin, causing collagen to break down, resulting in wrinkles. They also are a possible cause of melanoma, the deadliest of skin cancers, and may impact the immune system.

Of the eight pending TEA applications, doctors say ecamsule (also known as Mexoryl SX), Tinosorb S and Tinosorb M are the most effective, all offering long-range UVA protection.

Ecamsule is a proprietary ingredient of L’Oréal. In 2006 the company received FDA approval through the new-drug application process to use ecamsule in three currently marketed products, said Rebecca Caruso, a spokeswoman for L’Oréal USA. Two are moisturizers and one is a sunscreen that retails for $35.99.

But the approval was specific to the formulations, meaning the company doesn’t have the flexibility to use the ingredient in other products. L’Oréal has two pending TEA applications. In Europe—where more products with ecamsule are available—it has been widely used in a variety of products since 1991.

Ms. Caruso called ecamsule “highly effective,” adding, “We look forward to its approval by the FDA so that it can be made more broadly available for use in sunscreen formulations.”

Julie Russak, a dermatologist in Manhattan and clinical instructor at Mount Sinai School of Medicine, said it’s understandable why the FDA would be cautious in approvals for new sunscreen ingredients because of a paucity of research and concerns that some may be highly allergenic or affect estrogen levels.

“I know patients bring sunscreens with them from Europe and it’s very hard for us to give recommendations because we really don’t have much data” on such products, Dr. Russak said.

No such concerns have been cited for Tinosorb or Mexoryl, several doctors said. The filters have been used effectively outside the U.S. for a long time, according to Dr. Lim. The lack of UVA filters in the U.S. “does limit the ability of sunscreen manufacturers to manufacture good, broad-spectrum sunscreens,” he said.

Sonya Lunder, a senior analyst for the Environmental Working Group, a nonprofit advocacy group in Washington, D.C., said “not all the of the European sunscreen chemicals are good or better. But there are a handful that really stand out to us as worthy of consideration and would result in improvement for sun protection.”

In the U.S., the main chemical UVA filters are benzophenones, such as oxybenzone, and avobenzone. Chemical filters largely work by absorbing the sun’s rays. 

Experts say oxybenzone has a number of shortcomings. It can cause allergic reactions and studies have found that it is absorbed and detected in the blood stream and could possibly affect some hormone levels. It also only absorbs only a shorter form of UVA rays.

Meanwhile, avobenzone can break down in sunlight, experts say, and reduces the potency of octinoxate, a UVB filter common in the U.S., when combined with it.

Inorganic or mineral-based UVA filters titanium dioxide and zinc oxide, which don’t break down as easily in sunlight and generally are not allergenic, are better options, according to Lawrence Gibson, professor of dermatology at the Mayo clinic in Minnesota. These are physical blockers which protect the skin by either deflecting sun rays or reflecting them away from the skin, like a mirror.

But their large particle size makes them heavier in application, resulting in a whitish, chalky appearance that consumers find unappealing. Efforts to make the particles smaller have worked, but have raised safety concerns because they can penetrate the skin and potentially interact with cells. The studies have not been conclusive and most dermatologists still recommend such products.

New sunscreen labels in effect this year require a pass-fail test for UVA and UVB protection.

But critics like the Environmental Working Group say the test that products must pass to receive the “broad spectrum” label is weak. Ms. Lunder noted that in Europe the standards are more rigid: UVA protection has to be one-third of the SPF.

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