Sunscreen to Have Stricter Labeling to Protect Against Cancer-Causing UVA Light

June 14, 2011— -- New sunscreen labels will include a marking to show for the first time how well the product protects users against cancer-causing ultraviolet A (UVA) light, the U.S. Food and Drug Administration said today.

The agency's latest regulation recommends that sunscreen labeling be expanded to provide an indication of so-called broad spectrum protection that informs consumers whether the product sheilds them from both UVA and UVB light.

Sunscreen labels are already required to carry a Sun Protection Factor (SPF) level that informs users how well the product protects against UVB light, which primarily causes sunburn. Enhanced labeling on creams and lotions, expected to be implemented by next summer, will focus on UVA light, which is potentially more damaging because it penetrates the skin further than UVB and causes the skin to tan.

Consumers might think that the higher the SPF, the better the protection. But the SPF level doesn't offer insights into UVA protection. Product manufacturers have never before been required to provide labeling information regarding UVA protection.

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"We think the way we've done this can reduce consumer confusion about sunscreen," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation.

To get the broad spectrum claim, manufacturers will have to show that the amount of UVA protection proportionally increases as the SPF level increases. The product will also need to be SPF 15 or higher.

Sunscreens that meet the requirements of the test and are labeled as SPF 15 or above will be clearly marked as a product that "reduces the risk of early skin aging and skin cancer."

"We want to have breadth and strength in your sunscreen," Woodcock said. "Lower than SPF 15 may pass the broad spectrum test, but they can't say they're reducing skin cancer and damaging."

The agency has mulled over how best to test for UVA protection since 1978, when Frankie Valli released the title song to the summer movie hit, "Grease."

"We were having difficulty arriving scientifically at a standard test method that everyone could use and a way to relay that to the consumers in a way that would be effective," said Woodcock.

While the FDA's decision provided arguably one of the largest steps of sunscreen regulation by the agency, some consumer groups say the final testing method is not enough.

Regulators will use so-called "in-vitro" testing -- using glass dishes, rather than testing on humans -- to assess UVA strength, according to Mike Hansen, senior scientist at Consumers Union, which tests both UVA and UVB factors in its annual guide to the most effective sunscreens.

"We don't think the in vitro is as predictive," said Hansen. "We think it's best done together."

Both testing methods have their pros and cons, said Dr. Darell Rigel, past president of the American Academy of Dermatology. But, Rigel said, the new standard placed by the agency is one of the best advances in combinationUVA and UVB protection.

"What matters to me as a clinician everyday is that I have no idea how to tell my patients what's the best sunscreen," said Rigel. "Now, I have an easy way to tell my patients what to do. That's the most valuable thing."

Skin cancer is the most common form of cancer in the U.S. Dermatologists diagnose and treat more than 3.5 million cases of skin cancer each year, according to the American Academy of Dermatology. Nearly 20 percent of Americans will develop skin cancer in their lifetime.

The agency's final rule has additional changes, Woodcock said. All sunscreens will have to include a drug facts box on the back of the bottle, as seen on other over-the-counter medications.

Sunscreen will no longer be identified as sun block because such labeling implies inaccurate information, Woodcock said.

Additionally, manufacturers cannot make claims that the product will offer more than two hours of protection. They can no longer claim the product as water-proof or sweat-proof without indicating the length of time it can provide full protection.

The agency is also looking to change the maximum sunburn protection level from its recommended SPF 30 to SPF 50.

Although products higher than SPF 50 claim to provide stronger sun protection, Woodcock said, "we don't have sufficient data that any sunscreen higher than 50 has efficient sun protection."

Both kinds of UV light contribute to skin damage, including premature skin aging and skin cancer.

"Using sunscreen alone cannot protect against skin cancer or early skin aging," Woodcock said.