In a recent press release, The U.S. Food and Drug Administration has proposed a new regulations in regard to over-the-counter (OTC) sunscreen drug products. The new regulations sets standards for formulating, testing and labeling.
Until now, people was able to select sunscreens and tanning products based on the sunburn protection factor or SPF values. The higher the SPF the better protection you got for your skin from the damaging effect of sunlight.
However, the SPF only protect your skin from one portion of the sun light know as UVB, or Ultraviolet B. Sunlight is made of both visible light (which you obviously can see) and ultraviolet (UV) light (that we do not see it). Also, UV light can be divided in two types: 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. However, as said before, SPF factors only gives you information on the UVB portion of the sunlight.
Under the new set of regulation, that will be get in effect in the next few months, you will be able to make better informed decisions about sunburn protection drug products and tanning products. A new rating system is being proposed for the UVA portion of the UV spectrum. Under this system consumers will be able to identify the level of UVA protection offered by a product.
The FDA proposal will provide a ratings system for UVA sunscreen products on a scale of one to four stars (one star — low UVA protection, two stars — medium protection, three stars —– high protection, and four stars —– the highest UVA protection).
The press release also indicates that “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”
Additionally, the new proposed set of regulations mandates posting the following “Warning” statement in the “Drug Facts” box on all sunscreen and tanning product manufacturers”
“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 FDA proposal will change rules approved in 1999 for sunscreen labeling. IN addition the FDA proposes revises the existing SPF (UVB) testing procedures, allow new combinations of active ingredients, and asks for comments on the issue of nanoparticles.
Under the proposed amendment, the range for SPF values would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Previously, FDA had recognized only SPF values up to 30
FDA Proposes New Rule for Sunscreen Products. FDA Press Release. URL: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01687.html
2007 Sunscreen Proposed Rule. U.S. Food and Drug Administration. URL: http://www.fda.gov/cder/drug/infopage/sunscreen/default.htm