WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for physicians to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.
"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."
He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "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," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.
"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.
Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.
"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.
As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."
Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.