Tag: sunscreen


Very effective sunblock blocked by the FDA.

June 10th, 2015 — 11:33am

 

Border patrol K-9 unit trained to sniff out illegal sunscreen.

Sparky is especially trained to sniff out illegal sunscreen. Woof.

This is an article from the May/June 2015 King County Medical Society Bulletin.  It’s a little long and technical but just hang onto that attention span and read it!

Packing a Sunscreen Souvenir

Tourists Grab UVA Treatments Common Elsewhere, Illegal Here

By Barbara K. Gehrett, M.D.

Some international travelers are returning with pharmaceutical souvenirs – new UVA sunscreens available in Europe, Canada, Mexico, and other countries and not yet approved in the United States.

Ninety-five percent of the solar UV radiation that reaches earth is UVA.  It has a wavelength between 320 and 400 nanometers and is present during all daylight hours, summer or winter, cloudy or clear.  UVA passes through glass and penetrates deep into skin.  It is responsible for more damage to basal keratinocytes in the epidermis than UVB.

Most UVB damage occurs in the superficial layer of the epidermis, producing suntan, sunburn, and aging skin.  Protection from UVB with sunscreens reduces the risk of non-melanoma skin cancers.

Two short-acting, barrier-type UVA sunscreens have been approved for use in the U.S.  These are zinc oxide and oxybenzone.  Dermatologists argue that their protection is limited and requires repeated application because they break down quickly.

Ecamsule is a longer-acting “chemical filter” made by L’Oreal and is one component of a U.S. approved lotion, Mexoryl.  The FDA turned down the application to release ecamsule as an over-the-counter UVA sunscreen, although it has been available in Europe since the late 1990s.  It is regulated there as a cosmetic, which has a different standard than the drug category it falls into in the U.S.  All sunscreens in Europe must give both UVA and UVB protection.

Eight UVA sunscreen products have been languishing in line (one since 2003) for FDA consideration.  Congress and President Barack Obama attempted to pressure the FDA by passing the Sunscreen Innovation Act in December of 2014.  This new law requires the FDA to issue an approval or disapproval ruling within 60 days of receiving a complete application for sunscreen.   All eight of the new UVA sunscreens were expeditiously disapproved by the FDA early in 2015.

The FDA wants long-term data on safety before approval will be given.  Typically this means two Phase 3 clinical trials, which are expensive and time-consuming.  It is possible ;that future data on skin cancer protection from other countries would move the agency.  Or perhaps ;the procedural review taking place at the agency will result in a different set of criteria for sunscreens.

In the meantime, U.S. travelers stocking up on sunscreen  when they are outside the country are violating the Food, Drug and Cosmetics Act by importing unapproved drugs.  According to WebMD, the FDA does not generally pursue violators, unless the quantities involved are egregious.  One other work of warning:  online purchases should be made with caution, because of international counterfeiting of drugs.

Thanks for reading!  And keep using that lousy U.S. approved sun creen.  It’s better than nothing.   Dr. Lisa Lynn Sowder

General Health, Government and Politics, Skin Cancer, Skin Care, This Makes Me Cranky.

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