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Our Comments Regarding The
Proposted FDA Regulation for Sunscreen
written June 27, 2011

To begin with it should be noted that all the current hubbub regarding the new FDA Sunscreen guidelines are only proposed regulations that are scheduled to go into place in thesummer of 2012. Final regulations are still in the making.

The FDA's new regulations are being developed to help the consumers better understand what they are getting when they buy a bottle of sunscreen. The sunscreen manufacturers have been overstating claims of the effectiveness of their product. Let’s take those claims one by one:

Claim #1: High SPF, such as an SPF of 100 for example, provides a lot more sun protective than say SPF 30. Wrong! It certainly captures the consumers eye but, let us face it, high SPF ratings are just a marketing ploy. The difference between an SPF of 100 (99% UV block) and that of SPF 30 (98% UV Block) is only 1%. The FDA proposes to limit sunscreen manufacturers to an SPF of 50… using 50 SPF verses 30 SPF as the maximum rating would seem to be a compromise by the FDA for the manufacturers benefit since the difference in sun protection is negligible.

In the past, SPF has only been a measure of UVB (also called the sunburn ray) radiation and did not take into account UVA protection. Sunscreens will now have to pass FDA's broad spectrum test procedure, which measures a product's UVA protection relative to its UVB protection. It was not clear to us how they plan to test and rate the UVA penetration but, if the sunscreen does pass, the manufacture will be able to use a Broad Spectrum SPF rating indicating the amount or magnitude of overall protection.

Claim #2: Using sunscreen prevents skin cancer and premature aging caused by sun damage? It is interesting to note that scientist are considering the fact that geographical areas using more sunscreen have shown an increased incidence of skin cancer.

FDA Proposed wording for manufacturers: Only Broad Spectrum sunscreens (sunscreens that protect against UVA and UVB radiation) with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protective measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.

That said, sunscreen, no matter how high the SPF or how broad the spectrum, will allow damaging UV radiation to harm the skin if you stay out for a prolonged period of time. The amount of time varies with an individual's skin type, latitude, altitude, etc., but the bottom-line is, if you plan to be out for hours you are going to get damage! Sunscreen is an important tool for sun safety but is one of the last precautions to depend on. Clothing, sun hat, sungloves, etc. provide far safer and more sun protection than sunscreen.

Claim #3: "Waterproof”, "sweatproof" or "sunblock" claims. Manufacturers cannot label their sunscreens as "waterproof" or "sweatproof," or identify their products as "sunblocks," because these claims overstate their effectiveness. Sunscreens can also not claim to provide sun protection for more than 2 hours without reapplication, or to provide protection immediately after application (for example-- "instant protection") without submitting data to support these claims and obtaining FDA approval.

Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes.

The new regulations also include "Drug Facts" information on the back and/or side of the sunscreen container listing warnings and other important information for the consumer.

After 30 years in the making we are very happy to see a glimmer of something coming through the FDA to protect the consumer. Our concerns lie in the questionable FDA rating of UVA radiation and the pervasive opinion of the public to view sunscreen as their primary means of sun protection. If the FDA’s UVA rating system is not strict enough we will get what we have gotten in the past and that is an inaccurate measurement of a sunscreens ability to protect the skin. And, if people do not use sensible sun protective measures, such as being in the shade, wear sun protective clothing and hats, and rely on sunscreen only, they will not have done the most to keep their skin healthy, and may possible pay the price in later years.

FDA’s webpage regarding the new regulations

This material is provided for information only. It is not a substitute for your doctor or health care provider. If you have any health questions or concerns you should see your doctor or health care provider.

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