FDA: New Sunscreen Guidelines Delayed Six Months

Rhode Island Senator Jack Reed says "more consumers will likely get burned this summer" due to the FDA's delay in implementing stricter sunscreen-labeling guidelines

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Sunscreen confusion may continue through this summer. The U.S. Food and Drug Administration (FDA) announced on May 11 that it’s giving sunscreen manufacturers an additional six months to make labeling changes that will help users better protect themselves.

Last summer, the FDA told manufacturers they had until this June to revise their sunscreen labels in order to distinguish brands that could be labeled as “broad spectrum,” meaning they protect against both ultraviolet A and ultraviolet B rays, which contribute to skin cancer and early skin aging. The new guidelines also say brands cannot claim to be sweatproof or waterproof on their labels, to alert users that they must reapply the products.

(MORE: Sunburn and Indoor Tanning Still Putting Young People at Risk for Skin Cancer)

Manufacturers said they were having difficulty meeting the original deadline, which is less than a month away. So in a formal announcement, the FDA said it will give companies six more months, until December, to make the necessary changes. Smaller companies have an even more generous deadline of December 2013.

The agency argues that without the extension, there would be sunscreen shortages. “We asked for the additional time,” Farah Ahmed, chair of the sunscreen task force at the Personal Care Products Council, told USA Today. Ahmed said changing labels on thousands of products “is a huge undertaking” and that unprepared manufacturers wouldn’t be able to ship new products after June 18, resulting in shortages.

“The FDA took a major step backwards today, and as a result, more consumers will likely get burned this summer,” Rhode Island Senator Jack Reed told the Associated Press. Reed has long encouraged the FDA to enforce stricter sunscreen regulations.

(MORE: Study Finds Dramatic Rise in Skin Cancer Among Young Adults)

Sunscreen products do not need to be reformulated to meet the new guidelines, but the label revisions can take a lot of time, Ahmed told the AP. The FDA is still encouraging brands to quickly re-label and put those products in stores as soon as they can, and some companies have already done so.

When the guidelines are finally enforced, here is what the FDA says consumers can expect:

  • Broad-spectrum designation: Sunscreens that pass the FDA’s broad-spectrum test, to see if they protect against both ultraviolet A and ultraviolet B rays, may be labeled as “Broad-Spectrum SPF” on the front label.
  • Use claims: Only broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce skin-cancer risk and early skin aging if used as directed with other protective measures. Other sunscreens, including those with an SPF value between 2 and 14, can claim only to help prevent sunburn.
  • Waterproof, sweatproof and sunblock claims: Sunscreens cannot be labeled as waterproof or sweatproof, or be identified as a sunblock, because those words overstate their effectiveness. Sunscreens cannot claim to provide sun protection for more than two hours without reapplication or to provide immediate protection without having submitted data to obtain FDA approval.
  • Water-resistance claims: “Water-resistance” labeling must indicate whether the sunscreen is effective for 40 minutes or 80 minutes while swimming or sweating. Other sunscreens must include a recommendation advising consumers to use water-resistant sunscreen if swimming or sweating.
  • Drug facts: All sunscreens must include standard drug-facts information on the back or side.

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