Sunscreen Drug Products For Over-the-Counter Human Use, Proposed FDA Rule

More than 90% of all skin cancers are caused by sun exposure and sunscreens are a key weapon in the arsenal against the disease. While sunscreens have improved dramatically over the past several years, there was a need to update the governmental regulations associated with sunscreens especially regarding the institution of a UVA test method and product labeling.  Our knowledge of the dangers associated with UVA rays has grown significantly over the last few decades.  We now know that UVA plays a very direct role in skin cancer comparable to that of UVB.  Therefore, introducing a UVA test method will enable consumers to know how well the product protects against UVA rays as well as UVB rays.   --Perry Robins, MD, President, The Skin Cancer Foundation

Key Issues Addressed in the FDA Monograph

UVA testing:
Institution of a UVA test method so that consumers will know how well the product protects against UVA rays. 

SPF Cap: Sun Protection Factor’s (SPF) have been getting higher and higher. The FDA may limit how high this number can go.  SPF is a measurement of UVB.

Labeling: In order to help consumers better understand their sunscreen purchases, the FDA will mandate the use of very specific language.

The FDA will accept comments on this proposal for three months.  During that time, The Skin Cancer Foundation will share its positions on these issues with the FDA.  Sometime after the comment period, the FDA will release a final monograph.  At that time, sunscreen manufacturers will be required to conform to the final FDA rule.

UVA testing

FDA POSITION:  The FDA seeks to standardize test protocol for UVA protection by proposing a combination of in vivo and in vitro testing procedures. The proposed in vivo test is the persistent pigment darkening method, and the in vivo test is the transmission of UVA through sunscreen product placed on quartz plate.

Sun Protection Factor (SPF) is the standard measure of sunscreen efficacy related to UVB rays. Now that more and more products provide protection against UVA, a standardized product testing model needs to be approved in the US, along with an easy-to-understand labeling system for sunscreen products. In fact, to emphasize the effect of UVB on SPF, FDA proposes to re-name SPF from “sun protection factor” to “sunburn protection factor”.

Currently, two broad categories of UVA test methods exist:  in vivo, where the test is conducted on a living organism, and in vitro, where the test is conducted on tissue or another vehicle in the laboratory instead. The scientific community differs on whether in vivo or in vitro UVA testing is more meaningful, and opinions vary on the efficacy of test methods within those two broad categories. In vivo PPD, in vivo PFA, and in vitro Critical Wavelength, however, appear to have strong support.

  • The PPD and PFA in vivo -- pigment darkening or reddening is used as a biological endpoint.
  • In vitro Critical Wavelength test measures how much UV is transmitted and absorbed.

The Skin Cancer Foundation position:  The SCF agrees with the FDA position that a combination of in vivo and in vitro testing provides the most accurate measurement of UVA protection and supports using either a) in vivo PPD or PFA test or b) the critical wavelength method.

SPF Cap
FDA POSITION:  The FDA proposes to increase specific labeled SPF value from 30 to 50 and revise the collective term to 50+ for sunscreen products with SPF>50.

The Skin Cancer Foundation position: We believe strongly that products with a higher stated SPF (above 30) are essential for consumers who are at high risk for skin cancer, so the Foundation is in agreement with the FDA.  The percentage of UVB rays blocked at higher SPF levels may be significant to someone who: has a history of skin cancer, is extremely fair, has a suppressed immune system, or is taking medication that causes photosensitivity.

Labeling
FDA POSITION:  Revise the phrase “sun protection” to “sunburn protection”. 
There will be a rating system for UVA protection as well as UVB protection.

The front label of the sunscreen must include ratings for UVA and UVB protection

UVB:
Low

2-14 SPF

Medium

15-29 SPF

High

30-50 SPF

Highest

50+ SPF

UVA:
Low star1
Medium star2
High star3
Highest star4


If the product does not contain UVA protection, the package must say “no UVA protection”.

“Water-resistant” vs. “waterproof”
FDA position: If the product satisfies the corresponding FDA-recommended water resistance test, the product may carry one of these labels: water resistant, water/sweat resistant, or water/perspiration resistant, depending on protection levels shown in testing.  The term “waterproof” will not be used.

“Sunblock”
FDA position: The monograph does not include the use of the term “sunblock”; rather, it proposes labeling UVB and UVA protection levels as detailed above.

The Skin Cancer Foundation position: No sunscreen can provide 100% protection
From UVA or UVB rays.  The term “sunblock” is misleading and can, in fact, give people a false sense of protection.  Therefore, the SCF supports the position of the FDA.


Skin Cancer Foundation position: No sunscreen is 100% waterproof. The SCF supports the position of the FDA that “water-resistant” and “very water-resistant” are the terms to be used, and that “waterproof” should not be used.

“Sun Alert”
FDA position: in order to include the best scientific evidence concerning the relationship of sunscreen use to the prevention of sunburn, skin cancer, and premature skin aging caused by UV exposure, language for the revised “sun alert” includes a statement about limiting sun exposure and wearing protective clothing because FDA has tentatively determined that it is critical for consumers to understand the role of sunscreen use in a comprehensive sun protection program.

Skin Cancer Foundation position: The Foundation has always recommended a complete program of sun protection including:  seeking the shade, the use of sun protectivek clothing, and the use of sunscreen and sunglasses.
The Seal of Recommendation
The Skin Cancer Foundation Seal of Recommendation is currently awarded to more than 500 products which meet the testing criteria established by the Foundation’s Photobiology Committee (made up of five eminent dermatologists who are expert in the effects of sun exposure on human skin) for UVB testing. The Sun Protection Factor (SPF) rating is based on testing for protection against UVB only. The Foundation will require that all Seal holders verify their UVA claims which will make selecting a safe and effective UV protection product as easy as possible. The Foundation will also require that manufacturers follow the SPF and labeling guidelines in a timely manner. The Seal of Recommendation will provide consumers with an easy way to ensure they are getting a safe and effective sunscreen product that meets all of the FDA requirements helping to alleviate the confusion most consumers experience when selecting a sunscreen.


The first organization in the U.S. that committed itself to educating the public and medical professionals about sun safety, The Skin Cancer Foundation is still the only global organization solely devoted to the prevention, detection and treatment of skin cancer.  The mission of the Foundation is to decrease the incidence of skin cancer through public and professional education and research.  For more information, visit http://www.skincancer.org/, or call 1-800-SKIN-490.