The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC)sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.
"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," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "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."
Sunlight is composed of the visible light that we can see, and ultraviolet
(UV) light that we can not. 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.
The proposed regulation creates a consumer-friendly rating system for UVA
products designed to help consumers identify the level of UVA protection offered
by a product. The FDA proposal provides a ratings system 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
represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require
that the product bear a "no UVA protection" marking on the front
label near the SPF value.
Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes
through it. The second test measures a product's ability to prevent tanning.
This test is nearly identical to the SPF test used to determine the effectiveness
of UVB sunscreen products.
In addition, a "Warnings" statement
in the "Drug Facts" box will be required
of all sunscreen product manufacturers. The warning will say: "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." The
warning is intended to increase awareness that sunscreens are only one part
of a sun protection program.
"Many consumers incorrectly believe that the only way to protect themselves
from skin damage caused by the sun is to apply sunscreens," said Douglas
Throckmorton, M.D., 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 published in 1999 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 recognized SPF values up to 30+. Under the proposed amendment,
the range would be SPF2 to SPF 50+. SPF50 provides more UVB protection than
lower SPF values. Additionally, 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.
Labels: FDA. SPF, sunscreen, tanning, UVA, UVB
