Will FDA Heed Our Proposed Sunscreen Label Warnings And Protect The American Public?

We responded to the Food and Drug Administration’s (FDA) request for comments about the Sunscreen Monograph [Docket No: 1978N-0038] and hope it mandates that our recommended warnings be included on sunscreen labels.

The failure to heed and incorporate our proposed warnings will mean that FDA has—once again—decided to protect the vested financial interests of sunscreen companies rather than protect the American public.

The first sunscreen label warning we recommend is to place the wording shown below on all sunscreens incorporating UVB filters equal to or greater than SPF 15. The American public has the right to know that a sunscreen with an SPF 15 or higher prevents ultraviolet radiation from stimulating the cutaneous production of vitamin D—FDA will be derelict in its duties if it fails to let people know about this factor.

WARNING: Use of a sunscreen with a SPF of 15 or higher will prevent the cutaneous photosynthesis of vitamin D.

The second sunscreen label warning we recommend is to place the wording shown below on all sunscreens incorporating UVA filters. The American public has the right to know that a sunscreen with a UVA filter prevents development of photoprotective facultative pigmentation, better known by the public as a tan.

WARNING: Use of this sunscreen product will prevent the development of photoprotective facultative pigmentation, a.k.a., a tan.

As you would expect, the sunscreen industry and the dermatology community will stridently oppose these recommended warnings because they fear that incorporating them will have a negative effect on sales. However, if the new sun protection paradigm described below is adopted, sales of sunscreens actually may increase.

The old sun protection paradigm calls for the use of a high SPF sunscreen every day of the year no matter the season, time of day, skin type/subtype or level of facultative pigmentation (i.e., level of tan). The new sun protection paradigm recognizes that the first level of defense should be our genetically determined natural skin color (constitutive pigmentation); the second level should be an acquired/ adaptive tan (facultative pigmentation); and the third level should be the use of an SPF 4 or SPF 8 sunscreen. This new paradigm will be accepted by anyone who understands that Mother Nature’s natural way to protect our skin from skin damage is still the best.

Notwithstanding the fact that there has been one delay after another regarding updating the warnings on sunscreen products, FDA mandated that tanning lotions provide the warning shown below several years ago—even though it knew, or reasonably should have known, that the risk involved with these products was far less than the risk involved with sunscreens.

WARNING: This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risks of aging, skin cancer and other harmful effects even if you do not burn.

Therefore, since FDA mandated that tanning lotions include the above warning, and since the doctrine of “sauce for the goose is sauce for the gander” applies, there is no valid reason for FDA to decline to mandate that the two warning labels we have recommended be placed on sunscreen products. 

Patricia E. Reykdal owns and operates four tanning salons in Tucson, Ariz. Her husband, Donald L. Smith, is director of research of the Non-Ionizing Radiation Research Institute. Together, they have written more than 250 articles promoting sensible, moderate and responsible exposure to ultraviolet radiation. You can e-mail comments or questions to reyksmith@aol.com.