FDA Proposes New Rules for Sunscreens

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Ratings for UVA would be based on two tests. The first measures the sunscreen's ability to reduce the amount of UVA radiation that passes through it. The second measures a product's ability to prevent tanning. This test is similar to the SPF test used to determine the effectiveness of sunscreens to block UVB rays, according to the FDA.

Sunscreens would carry a "Warnings" statement in the "Drug Facts" box. The warning will say that "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen."

In addition, the label would also warn that "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." Directions would tell people to reapply sunscreen "at least every 2 hours."

The intent of the warning is to alert consumers that sunscreen is only a part of protecting yourself from sun exposure, Holman said.

According to the FDA, the proposal has guidelines for testing that manufacturers need to do to support their claims. Under the rule, sunscreens could have a maximum SPF of 50+ unless test data shows that a higher number is warranted.

In addition, the definition of SPF would change from "sun protection factor" to "sunburn protection factor." This change will prevent "the impression of solar invincibility and a false sense of security," according to the agency's proposal.

One expert thinks it's about time the FDA set standards for UVA protection.

"This is an important step forward," said Dr. James Spencer, a professor of clinical dermatology at Mount Sinai School of Medicine in New York City, who also is in private practice in St. Petersburg, Fla. "UVA protection is important for the prevention of skin cancer and wrinkles," he said.

In fact, Spencer would like to see the same star rating system proposed for UVA to replace the SPF number used for UVB.

This label changes were partly spurred by a report from a Washington, D.C.-based nonprofit, the Environmental Working Group, in June. The EWG faulted the FDA for missing a deadline imposed by Congress to set sunscreen safety standards by last year.

In their report, the group found that of 386 sunscreens with SPF ratings higher than 30, 13 percent protected users from UVA radiation.

More information

Find out more about sunscreen use and sun safety from the U.S. Food and Drug Administration.