The proposal introduces new standards for the formulating, testing and labeling of over-the-counter sunscreen products, in particular introducing a rating system for UVA protection.
The UVA rating system works on a scale of one to four stars, with one star providing a low level of protection, two providing medium, three high, and four providing the highest level of protection available in over the counter sunscreens.
If the sunscreen is not awarded even a one star for low level UVA protection the proposals suggest that 'no UVA protection' be required on the front label near the SPF value.
"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" , said Andrew C. von Eschenbauch, commissioner of food and drugs.
In addition to the rating system, the new proposals would require a warning statement to appear in the 'Drug Facts' box on the label stating that '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' .
It is hoped that such a warning will both remind consumers of the dangers of sun exposure, and that sunscreen is only one part of a range of possible measures of sun protection.
The regulation will also revise the existing SPF (UVB) testing procedures, and the FDA will officially recognise SPF values of up to 50+, as opposed to a maximum of 30+ under the old regulations.
Furthermore, new combinations of active ingredients will be recognised under the proposals, and the FDA are asking for comments on the issue of nanpoparticles in sunscreens.
The FDA has announced a time period of 90 days, until November 26, 2007, during which it will accept comments and suggestions on the proposals, which can be submitted through the FDA website.
The new proposals follow a campaign launched earlier this summer by Congresswoman Nita Lowey, calling for an improvement to the legislation of sunscreen products, in particular their UVA protective capacities.
Similar recommendations were put into place last year, in the EU, aiming to improve awareness of the dangers of UVA damage to skin and to ensure that consumers have the means of identifying products that provide adequate protection for both types of UV rays.
More recent EU regulation includes the eradication of the terms 'total protection' and 'complete sunblock', as the EC claim that even the high SPF let some radiation through, with the industry being asked to amend all labels by next year.
Such measures may also become a reality in the US, with lobby group the Environmental Working Group claiming that at least 51 per cent of sunscreens currently on the US market contain false information such as 'providing all-day protection' or 'blocks all harmful rays'.