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FDA: Sunscreens Will Get More Scrutiny, New Labels

Savannah Stidham gets smeared with sunscreen during a visit to a beach in Fort Lauderdale, Fla., in 2006.
Joe Raedle
Getty Images
Savannah Stidham gets smeared with sunscreen during a visit to a beach in Fort Lauderdale, Fla., in 2006.

For the first time in more than 30 years, the Food and Drug Administration has revamped its standards for sunscreens. The changes, which take effect in a year, should make it easier for people to find the right sunscreen to protect against sunburn, reduce the risk of skin cancer and prevent premature skin aging.

Right now, manufacturers are only required to say how their products do in protecting against ultraviolet B (UVB) — not ultraviolet A (UVA). UVA rays are the ones linked to premature aging, while UVB is the culprit for sunburn. Both types of rays can lead to skin cancer.

"This is a significant day for us," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, at a FDA media briefing Tuesday. She said the changes are part of the agency's push "to ensure sunscreens meet modern day standards."


Sunscreen products that pass FDA's test for protection against UVA and UVB rays will be labeled broad spectrum. Products that are both broad spectrum and at least SPF 15 may be labeled to say they reduce the risk of skin cancer and the risk of early skin aging.

Under the FDA's new rules, suncreens will no longer be able to tout SPF ratings higher than 50. "We don't have sufficient data that shows protection greater than 50," said Woodcock. Products that don't have broad spectrum or SPF 15 will carry a warning label that says the product hasn't been shown to reduce skin cancer and aging.

Click on sunscreen for a look at the FDA's new label.
Click on sunscreen for a look at the FDA's new label.

Labels such as waterproof or sweatproof also won't be permitted. Instead, Woodcock said, "Water resistant claims must have labeling that includes the amount of time a person can get sun protection when swimming or sweating."

The last time the FDA developed rules to ensure the safety and effectiveness of sunscreens in the U.S. was during the Carter administration back in 1978. Both Consumers Union and the Environmental Working Group, a public health and environment non-profit organization, have been urging the FDA to update its rules on the safety and effectiveness of sunscreens.


"In general this is a positive step forward," Michael Hansen, senior scientist at Consumers Union, told Shots. "It's great to have broad spectrum protection but if you look at how they do the UVA test, it's an in vitro test, it's a test that's done in the lab." Hansen would have been happier if the FDA had also included tests using people.

Woodcock also mentioned that the FDA would continue to look into the safety of the ingredients used in sunscreens. Zinc oxide or titanium dioxide, used to block sunlight, are sometimes processed into tiny particles, called nanoparticles. Experts have questioned the safety of nanoparticles, but Woodcock said today that FDA tests found no risk.

Currently, more than 3.5 million cases of skin cancer in more than 2 million people are diagnosed each year, according to the American Academy of Dermatology. About 1 in 5 Americans will get skin cancer at some point in their lives. "The number of cases continues to rise faster than other cancers," said Ronald L. Moy, a dermatologist who is president of the American Academy of Dermatology, said at the briefing.

The deadliest kind of skin cancer is melanoma, the most common cause of cancer in people in their 20s, especially among women, according to the academy. "We continue to spread the word that ultraviolet rays cause cancer," Moy said.

Consumers will begin to see these labeling changes by next summer. In the meantime, Woodcock suggests following the dermatology group's guidelines:

  • Apply sunscreen with an SPF higher than 30 every 2 hours
  • Wear hats, clothing and sunglasses
  • Or just stay in the shade
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