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New Sunscreen Labeling Changes Finally Out

June 14, 2011

The long-awaiting FDA sunscreen labeling changes were presented today at  a press conference, and represent sweeping changes in the way sunscreens can be marketed.   The new regulations are being phased in by the summer of 2012.  “For now, I would follow the recommendations of the American Academy of Dermatology,” said Janet Woodcock, M.D., director of the Center for Drug Evaluation at the FDA.   The ADA recommends using an SPF of 30 or higher. Here are the major changes:

  • Sunscreens will have to put the SPF number and whether the product is broad spectrum on the front of the bottle if it does protect against both ultra violet A and ultra violet B.
  • If the SPF is 15 or higher and is broad spectrum, the sunscreen can claim that it can reduce skin cancer and skin aging. If the SPF is lower or there is no broad spectrum coverage, the sunscreen cannot make these claims.
  • There will have to be a warning statement on sunscreens that don’t offer this protection.
  • There will be a drug facts box, similar to those on over-the-counter drugs, which includes active ingredients, uses, warnings, directions and inactive ingredients.
  • Directions state:
    • apply liberally 15 minutes before sun exposure.
    • Reapply after 40 minutes of swimming or seating
    • Immediately after towel drying
    • At least every two hours.
  • Sunscreens will not be able to make claims of long-lasting protection for more than two hours.
  • Sunscreens will not be able to claim they are waterproof of sweatproof because they promise more protection that is supported by the data.
  • Sunscreens can only claim water resistance for up to 80 minutes and need to indicate how long its resistant on the front of the bottle.
In addition, the FDA is researching the safety of spray sunscreens. For now, it’s prudent to hold your breath while spraying it on, because of concerns about inhaling the aerosols.
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2 Comments leave one →
  1. Tom Simon permalink
    February 26, 2012 1:30 am

    Dear Ms. Tarkan:

    I read your article “Aging of Eyes is Blamed for Range of Health Woes” with great interest but I am now confused. The piece seems to say that high levels of melatonin are good for you and blue light filtered out by older peaople ( my wife and I are 78) diminishes the amount of melatonin produced. On the other hand, one passage states: “The amount of blue light that significantly suppressed melatonin in the younger women had absolutely no effect on melatonin in the older women”. If blue light has no effect on melatonin production in older persons, why does it matter if blue light is filtered out by their eyes? Please explain. Thank you.

    • ltarkan permalink*
      February 26, 2012 8:18 am

      Hi Mr. Simon,
      Thanks for writing. Sorry I haven’t updated my blog to reflect my recent work. Need to do that! The study showed that younger women needed much less blue light, because their eyes let more in, to suppress the melatonin. The key word is amount. The amount needed to suppress it in the younger women did nothing for the older women, meaning that the older women would need longer exposure to blue light get the same effects as the younger women. That’s why these experts recommend older individuals get more sunlight exposure. But they’re not saying to overdo it! You need to protect your skin as well. I hope this clears it up.
      best,
      Laurie

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