Askanesthetician's Blog

An esthetician explores skincare issues and concerns

33 Years In the Making: The FDA Unveils New Sunscreen Regulations June 15, 2011

It only took 33 years but the FDA is finally finalizing new and improved rules to regulate the labeling and sale of sunscreens in the United States.  Here are the highlights of these new rules:

  • Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
  • Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • “Waterproof, “sweatproof” or “sunblock” claims. 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.
  • Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

The above changes will become law in a year.  Interestingly one important change has, for the moment, been left out of the new rules:

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.

 Additionally, the FDA is going to study spray sunscreens to determine what level of protection they provide and if they could be toxic if inhaled.  The FDA is also going to reexamine 17 sunscreen ingredients.

Though this has been a long time coming I applaud the FDA’s new rules though I would love for there to be a ban on SPF 50 or higher when the new rules go into effect in a year.


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