New Sunscreen Labeling Changes Finally Out
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.