FDA Proposes Changes to Sunscreen Ratings

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Carolyn Vachani, RN, MSN, AOCN
Abramson Cancer Center of the University of Pennsylvania
Last Modified: August 26, 2007

The sun produces the sunlight that we see and two types of ultraviolet rays that we cannot see, called UVA and UVB. These ultraviolet rays are actually radiation, which can cause skin damage. The ozone layer shields us from most of this radiation, but some UV light gets through and causes skin changes. UVB rays are primarily responsible for sunburns. Sunburns are particularly dangerous for children, as this is a strong risk factor for the development of melanoma. UVA light penetrates the skin more than UVB light does, and causes tanning. Both types of UV light contribute to skin cancer, premature skin aging, wrinkling, freckles, and age spots. With this knowledge, it seems obvious that we need to protect ourselves from both UVA and UVB rays, but are we?

When you go to the store and purchase a sunscreen with a high sun protection factor (SPF), you think you are doing your best to protect your skin from damage, but that isn't the whole story. SPF ratings only address UVB protection, in other words, the ability of the product to protect against sunburn. So, what about UVA? There are no accepted standards for rating the UVA protection of a product and no other countries have addressed UVA protection.

The U.S. Food and Drug Administration (FDA) have spent several years reviewing the available testing methods for UVA ratings and have identified two tests that they propose become standard. One test will determine a sunscreen's ability to reduce the amount of UVA light that passes through it, and the other test will determine a sunscreen's ability to prevent tanning. These results will be combined to generate a single UVA rating, which will be the lower of the two values. This rating will be on a four star scale, from low protection to the highest available. If a sunscreen has not been shown to provide any UVA protection, the FDA proposes the label contain the statement "No UVA Protection".

Star Category

Corresponding Rating

sunscreen 1 star low

Low Protection

sunscreen category: 2 stars medium

Medium Protection

sunscreen category: 3 stars high

High Protection

sunscreen  category: 4 stars highest

Highest Protection Available

You may wonder why use a number for SPF (UVB protection) and a star system for UVA? The FDA feels consumers are very familiar with the SPF ratings, which have been used for over 30 years, so they did not want to change them. Having two separate numerical scales for the ratings could cause confusion as well. The FDA hopes that two distinct rating systems will provide the clearest information for the consumer. The proposed system will appear on packaging as seen below.

sunscreen 2 sunscreen 3

In addition to the rating scale, proposed labeling will include a "sun alert statement" under "Warnings". This will advise consumers that sunscreen is only one piece of sun protection. Other important components include avoiding peak sun hours or extended sun exposure and wearing protective clothing, hats and sunglasses. Sunscreen must be reapplied at a minimum of every two hours and, regardless of the labeling, must be always be reapplied after swimming or sweating.

The FDA currently only recognizes SPF up to 30+, but the proposed changes will expand this to 50+ (currently available testing cannot validate ratings higher than 50). In addition, the "sun protection factor" would be renamed "sunburn protection factor". The proposal will also make some changes to the existing testing for UVB ratings and allow new combinations of active ingredients, which are more effective and already used in Europe .

Don't expect to see these changes anytime soon. The FDA is accepting comments on the proposal until November 26, 2007 via their website and then the regulations would give manufacturers time to institute the changes. In addition, they are also inviting public feedback on appropriate ways to test the effectiveness of novel sunscreen dosage forms, including mousses, foams, sprays, and towelettes. These formulations are readily available, but there is no standard way to test their effectiveness and it is uncertain how well consumers apply protection with these methods. Remember, when applying sunscreen, it takes about 2 tablespoons of lotion to cover an average adult appropriately.

For more information on the proposed regulations, visit the FDA website. See this previous article on sun safety for more information.