FDA announces long-awaited new rules for sunscreens


Woman applying sunscreen. (BIGSTOCKPHOTO)
June 14, 2011

For the first time, sunscreens will have to prove they provide good protection against both forms of the sun’s dangerous ultraviolet rays to claim they reduce the risk for skin cancer, sunburns and wrinkles, according to long-awaited federal rules unveiled Tuesday.

Only sunscreens that pass a test that shows that they shield skin from both ultraviolet A (UVA) and ultraviolet B (UVB) rays will be allowed to be labeled “broad spectrum,” and only those that also have an sun protection factor (SPF) rating of at least 15 can claim that they protect against sunburn, wrinkles and skin cancer, according to the Food and Drug Administration’s new requirements.

Sunscreens that do not meet those standards will have to carry prominent warnings that they do not protect against skin cancer or wrinkles, the FDA announced.

In addition, the agency is barring the use of the term “sunblock” as well as claims that sunscreens are “waterproof” or “sweat-proof,” saying those terms are inaccurate. Sunscreen makers will only be allowed to claim that products are “water-resistant” and will have to specify whether they work for 40 or 80 minutes. Those that do not must carry warnings advising people to use a water- resistant product if they are going to be exposed to water or sweat.

“These changes will help people make better-informed decisions about how to use sunscreens and allow them to more effectively protect themselves and their families,” said Janet Woodcock of the FDA’s Center for Drug Evaluation and Safety.

The FDA also plans to ban the use of any SPF ratings above 50, saying there is no evidence to show that any products provide such protection. Currently, some companies claim SPF protection of 100 or higher.

“We don’t have sufficient evidence data to show that sunscreen with SPF values greater than 50 provide greater protection for consumers,” Woodcock said.

Sunscreen makers could, however, submit data to support including higher SPF values, the agency said.

The moves are designed to eliminate the confusing and misleading array of ratings and claims on sunscreens and fight the leading cause of cancer in the United States.

The government’s plans to regulate sunscreens has been in the works for 33 years, with work beginning in 1978. A 1999 proposal never took effect after sunscreen makers objected, and a 2007 proposal for a four-star system was shelved as being too confusing.

The new rules go into effect in 2012, but Woodcock said she hoped some companies would start complying sooner.

Currently, the FDA only requires testing for UVB, which is the basis of SPF ratings. An SPF rating is how much time is needed to get a sunburn on protected vs. unprotected skin. An SPF rating of 15, for example, means it would take a person15 times longer to burn wearing that sunscreen compared to someone using nothing.

Both UVB and UVA radiation contribute to sunburn, skin cancer and “premature skin aging,” the agency said, but UVB radiation is the primary cause of skin cancer. More than 1 million Americans are diagnosed with skin cancer each year, making it the leading cause of cancer, and the number of people being diagnosed with the disease has been rising. While most skin cancers are curable, more than 68,000 Americans are diagnosed each year with melanoma — the most dangerous form— and an estimated 8,700 die.

An SPF rating is how much time is needed to get a sunburn on protected vs. unprotected skin. An SPF rating of 15, for example, means it would take a person15 times longer to burn wearing that sunscreen compared to someone using nothing. Under the new rules, products that have SPF values between 2 and 14 may be labeled as “broad spectrum” if they pass the required test, but only products that are labeled both as broad spectrum and have SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, the FDA said.

In addition, the agency will begin accepting data about the safety and effectiveness of sunscreen sprays and comments on possible warnings for sprays.

The new rules were praised by skin cancer experts, who also recommended that people minimize their sun exposure by staying indoors and taking other common-sense steps such as wearing hats, pants and long-sleeved shirts.

“There are a few easy things you can do to protect your skin from ultraviolet radiation. And today, the FDA’s new sunscreen labeling requirements make it even easier for us to all do that,” said Ronald L. Moy, president of the American Academy of Dermatology.

Despite concerns that some ingredients in sunscreens, particularly a new class of extremely small substances known as “nanoparticles,” might be dangerous, Woodcock said FDA testing has concluded that they do not penetrate the skin and are therefore safe.

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