What do the new FDA requirements for sunscreen labels mean?

Does trying to figure out the label on sunscreen drive you crazy? Do you stand there in the sunscreen aisle scratching your head about how much  SPF do you need? If an SPF of 30 is good, is 100 better? Should they be waterproof? Sweatproof? Too many choices!

This week the Federal Drug Administration (FDA) announced significant changes to sunscreen products in the hope that picking a sunscreen won’t be so confusing. The regulations will help consumers decide how to buy and use sunscreen, and allow them to more effectively protect themselves and their families from sun-induced damage.  They will also ensure that sunscreens meet modern-day standards for safety and efficacy and are based on the latest science available.

Prior rules on sunscreens dealt almost only 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. After reviewing the latest science, the FDA decided that they could now more accurately measure the amount of UVA protection and UVB protection a sunscreen contained.

If a sunscreen has enough protection against both UVA and UVB rays, it can be labeled “Broad Spectrum.” 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, such as limiting time in the sun and wearing protective clothing.

In a nut shell, the new regulations do the following:

  • 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. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described below.
  • 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. No sunscreen is completely waterproof, sweatproof or can totally block the sun’s rays!  Sunscreens 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. This is similar to the labels found on most other over-the-counter medications. It includes a list of the active and inactive ingredients, warnings and directions for use.

This ruling does not take effect until next summer, although you may see the new labeling used before that time. This is an example of the new sunscreen labels.

BTW- Dermatologists don’t usually recommend that you use sunscreen with SPF’s over 50. At that level, you are already blocking 97% of the UV rays. Going above this only adds about one additional percent of blockage, but at a much higher dose of drug.

Michele R. Berman, M.D. was Clinical Director of The Pediatric Center, a private practice on Capitol Hill in Washington, D.C. from 1988-2000, and was named Outstanding Washington Physician by Washingtonian Magazine in 1999. She was a medical internet pioneer having established one of the first medical practice websites in 1997. Dr. Berman also authored a monthly column for Washington Parent Magazine.

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