FDA cracks down on sunscreen claims, bans 'sunblock'

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

The Food and Drug Administration (FDA) also is barring use of "sunblock" as well as claims that sunscreens are "waterproof" or "sweat-proof," saying those terms are inaccurate.

"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.

Under the new rules, to take effect in 2012, only sunscreens that pass a test that shows 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 a sun-protection factor (SPF) rating of at least 15 can claim they protect against sunburn, wrinkles and cancer.

Sunscreens not meeting those standards will have to carry prominent warnings that they do not protect against skin cancer or wrinkles.

Manufacturers also will be allowed to claim only that products are "water-resistant" and will have to specify whether they work for 40 or 80 minutes. Those that don't must carry warnings advising people to use a water-resistant product if they are going to be exposed to water or sweat.

The FDA also plans to ban the use of any SPF ratings above 50, saying there is no evidence to show any products provide such protection. Some companies now 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, however, could 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. 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.

While the new rules won't take effect until next year, Woodcock said she hoped some companies would start complying sooner. Manufacturers with less than $25,000 in annual sales will have two years to comply.

The FDA now requires testing only for UVB, the basis of SPF ratings.

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, and the number of people 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 person 15 times longer to burn wearing that sunscreen compared to someone using nothing.

Under the new rules, products with SPF values of 2 to 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.

The agency also 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 sun exposure by staying indoors and taking other common-sense steps such as wearing hats, pants and long-sleeved shirts.

"Now, we'll be able to tell patients which sunscreens to get," said Dr. Henry Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a spokesman for 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, the FDA's Woodcock said testing by the agency has concluded they do not penetrate the skin and therefore are safe.

Information from The New York Times is included in this report.