FDA proposes new rules for rating sunscreen products

WASHINGTON The Food and Drug Administration has proposed a new regulation for sunscreen products, including a new UVA rating system and sun warning information.

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," stated Andrew von Eschenbach, FDA commissioner. "Under today’s proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

To help protect consumers, the FDA is proposing a ratings systems for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would mean high protection and four stars would mean the highest UVA protection available in an OTC sunscreen product.

If a product does not provide at least a low level (one star) of protection, the FDA is proposing to require that the product bear a "no UVA protection" marketing on the front label near the SPF value.

In addition, a "warnings" statement in the "drug facts" box would be required of all sunscreen product manufacturers. The warning would read: "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen."

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," stated Douglas Throckmorton, deputy director of FDA’s Center for Drug Evaluation and Research. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

When finalized, the proposed regulation would amend the existing OTC sunscreen rule that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had SPF values up to 30+. Now, the range would be from SPF2 to SPF50+. Furthermore, the proposed rule revises the existing SPF (UVB) testing procedures; allows new combinations of active ingredients; and asks for comments on the issue of nanoparticles.

FDA is accepting comments on the new rule for 90 days until Nov. 26, 2007.