The Impact of the FDA Final Regulations on Sunscreen

Although science and technology have advanced over the past several years to dramatically improve the safety and efficacy of sunscreens, there has long been a need to update the governmental regulations associated with them – particularly in the areas of UVA protection and product labeling. On June 14, the FDA announced its long-awaited final regulations on sunscreen labeling, which will help the public make more educated and informed sun protection decisions.

The announcement of the new regulations highlighted the importance of UVA protection in the prevention of skin cancer and premature skin aging, and affirmed the safety of sunscreens that meet FDA standards, noting that the benefits of regular sunscreen use far outweigh any potential risks. Here, the key points for consumers in the FDA’s new sunscreen regulations:

  • Sunscreens may be labeled “broad-spectrum” if they provide “proportional” protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. In other words, a product with an SPF of 15 (which refers directly to its UVB protection) must have a comparable level of protection against UVA to be considered broad-spectrum.
  • Only broad-spectrum sunscreens with a Sun Protection Factor (SPF) of 15 or higher can state that they reduce the risk of skin cancer and premature skin aging if used as directed along with other sun protection measures.
  • Sunscreens with an SPF of 2-14 or that are not broad-spectrum will be required to bear a warning label stating that the product has not been shown to reduce the risk of skin cancer or premature skin aging.
  • The terms “sunblock,” “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.
  • A sunscreen may claim to be “waterresistant,” but must specify if it offers 40 minutes or 80 minutes of protection when swimming or sweating, based on standard testing. Sunscreens that are not water-resistant must include instructions to use a water-resistant sunscreen if swimming or sweating.
  • Sunscreens cannot claim to provide sun protection for more than two hours without reapplication, unless the manufacturer provides test results proving that the product offers longer protection.

In its summation, the FDA noted that the ingredients in sunscreens marketed today have been used for many years, and the agency has no reason to believe they are unsafe for consumer use. The FDA emphasized, however, that sunscreen alone is not enough, and should be used in conjunction with a complete sun protection regimen, including shade-seeking, sun avoidance during the hours of most intense sunlight, and sun-protective clothing, including long pants and long-sleeved shirts, hats and sunglasses.

Sunscreen manufacturers will have one year to comply with the FDA rulings; smaller companies will have two years.