FDA Announces New Requirements for Sunscreen Products

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The U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens today.  The FDA website has information to help consumers understand the new requirements and what is important to know when buying and using sunscreen.  Here’s a summary:

Q. Why is FDA making changes to how sunscreens are marketed in the United States?

A.  Prior rules on sunscreens dealt almost exclusively with protection against only ultraviolet B (UVB) radiation from the sun, and did not address skin cancer and early skin aging caused by ultraviolet A (UVA) rays. The FDA now has a test procedure that measures both UVA and UVB protection.   Suncreens that pass the test are allowed to be labelled as “Broad Spectrum”.  The designation of broad spectrum will give consumers better information on which sunscreen products offer the greatest protection from both UVA and UVB exposure that can lead to an increased risk of skin cancer.

Broad Spectrum sunscreens with SPF values of 15 or higher help protect against not only sunburn, but also skin cancer and early skin aging when used as directed with other sun protection measures. These sun protection measures include limiting time in the sun and wearing protective clothing.  If a product is labeled with an SPF, but not “Broad Spectrum”, the SPF only indicates protection against sunburn.

Q. How does this new rule affect claims of “waterproof, “sweatproof” or “sunblock”?

A:  Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.

Q. What does the Proposed Rule address?

A. The proposed rule, if finalized, would limit the maximum SPF value on sunscreen labels to “50 +” because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

Tips to Reduce Your Risk of Skin Cancer from Sun Exposure

Regularly use a Broad Spectrum sunscreen with an SPF value of 15 or higher in combination with other protective measures such as:

  • Limiting time in the sun, especially between the hours of 10 AM and 2 PM when the sun’s rays are the strongest.
  • Wearing clothing to cover skin exposed to the sun (long-sleeved shirts, pants, sunglasses, and broad-brimmed hats).
  • Using a water resistant sunscreen if swimming or sweating.
  • Reapplying sunscreen, even if it is labeled as water resistant, at least every 2 hours. (Water resistant sunscreens should be reapplied more often after swimming or sweating, according to the directions on the label.)

More information is available at the FDA website under OTC Sunscreen.

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