FDA: New Rule for Sunscreen Products

The U.S. Food and Drug Administration (FDA) has proposed a new rule for sunscreen products, including a new UVA rating system and sun warning information.

The FDA 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.

The FDA reports that because consumers have been able to identify the level of UVB protection for more than 30 years, the new rule is designed to also alert them to the level of UVA protection.

According to the FDA, sunlight is composed of the visible light that humans can see, and ultraviolet (UV) light is composed of the light that humans cannot see. There are two types of UV light – UVA and UVB. UVA light is responsible for tanning, and UVB is responsible for sunburn. Both can damage the skin and increase the risk of skin cancer.

Skin cancer is the abnormal growth of skin cells. It most often develops on skin exposed to the sun, but it can also occur on areas that are not ordinarily exposed to sunlight. Skin cancer is generally divided into two stages, local (where the cancer affects only the skin) and metastatic (where cancer has spread beyond the skin).

Researchers estimate that more than one million new cases of skin cancer will be diagnosed in the United States this year. One out of five Americans will develop some form of skin cancer during their lifetime.

The FDA reports that 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. Additionally, 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, the FDA is proposing that such products be required to 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.

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. The FDA is also amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, the FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. Products that are SPF50 provide 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.

The FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form.

For more information about integrative therapies that may help block ultraviolet rays, please visit Natural Standard’s Herbs & Supplements database. For more information about skin cancer, please visit Natural Standard’s Conditions database.

 

Comments

[Heidi]

As the number of skin cancer cases continue to increase, I think it's super important that consumers know what they're buying. I'm glad to see that the FDA is regulating a consumer-friendly rating system for sunscreen.

[D. Scully]

I am glad to see that the FDA is taking steps to help people understand how much protection from sunburn they can get from different types of sunscreen. I'll admit that I'm confused by the current ratings. I had a friend who had skin cancer at 20, though, so I always buy the highest SPF I can find.

[Carol]

I also agree that this is great news. I'm definitely one of the consumers who would benefit from such a rating system. In fact, I'm still unsure of what the SPF actually means. I know it has something to do with how long the product protects you from the sun, and the higher the number, the longer you are protected. Can anyone break this down for me?

Also, what is the different between sunscreen and sunblock?

[Veronica]

This is a great idea, and I am glad to see that this sort of action is being taken. It is easy to be confused by the current rating system, and I don't think consumers really understood what they were getting before. I know some people thought that wearing sunblock would prevent them from getting a tan. These misconceptions need to be cleared, and this new system should be a great help. People will now be better educated about what they are putting on their skin and other preventative methods against skin cancer.

[Kathy]

Are children more susceptible to sunburn than adults?

[dalz]

To answer Carol's question:

Sunblocks scatter and reflect UVA/UVB and visible light. It's what you normally see painted on people's noses, lips or ears. Sunblocks most commonly contain zinc oxides and titanium dioxide.

Sunscreens, on the other hand, are chemical compounds and so are considered to be drugs under the FDA guidelines. Sunscreens absorb specific wavelengths of light. They can be used for more prolonged periods of protection.

[A. Krychek]

It's wonderful that such efforts are being put forth to curb the recent incline of skin cancer cases, but I regret the notion that most of these efforts are fruitless. I also had a friend that developed skin cancer at a young age and put together a fascinating program called "Pale is the New Tan" at my college. Everyone seemed really moved by the program, yet continued to sunbathe and go tanning on a regular basis. Today's youth is more concerned with appearance than the side effects of their actions - just look at how many people still smoke cigarettes. I think most people would be more concerned with better ways to safely look tan (i.e. sunless tanners that look natural, are odorless, dry quickly, etc.) than better ways to avoid one altogether.

[Linda]

I agree with everyone that the new FDA rule is a good thing and that consumers should be more aware of what they are buying. Carol – SPF stands for “sun protection factor,” and the numbers stand for the percentage of UVB rays blocked.

I have heard that any sunscreen with an SPF over 30 doesn’t really matter because it blocks about 96% of UVB rays. However, I have recently read that consumers do not put as much sunscreen on as they test in the labs. That means that if you put on SPF 30 you might be getting about SPF 15 in reality. So I think it’s also a good idea that they’re making an SPF 50 because then you might actually get the SPF 30 that you need.

[exposed treatment]

ViDoma Naturals Acne Gel is is designed to fight the bacteria and inflammation that cause skin problems, with natural ingredients like aloe vera, jojoba, rice bran oil and calendula oil.