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Executive Summary

HERBERT LABS' PHOTOPLEX SUNSCREEN WITH PARASOL 1789 UVA absorber and Padimate-O for UVB absorption received new drug application (NDA) approval from FDA Sept. 30. Photoplex Broad Spectrum Sunscreen Lotion is the first NDS'ed sunscreen to contain Givaudan's UVA blocker 4-tert butyl-4-methoxydibenzolymethane. The supplier had stopped selling Parsol 1789 in October 1986 after receiving a regulatory letter from FDA, challenging the ingredient as an unapproved new drug. Parsol 1789 was originally introduced in the U.S. in 1984. It has been available abroad since 1981. The Herbert sunscreen formula combines 3% Parsol 1789 and 7% Padimate-O in a lotion base. The UVB-absorbing padimate-O provides a sun protection factor (SPF) 15+. Herbert says that clinical studies have shown that Parsol 1789's protection against photoaging UVA rays, or longwave radiation, is significantly greater across the full absorption spectrum than the most widely used sunscreen, oxybenzone (octyl dimethyl PABA). The UVA absorption spectrum also represents the range in which most photosensitizers are active. Herbert Labs, a subsidiary of SmithKline's Allergan division, filed an NDA for the formula in April 1985. The Photoplex NDA has been "approvable" since late December but final approval was delayed pending FDA-requested labeling changes. Photoplex will be marketed as an OTC drug available primarily through pharmacists. It will reach stores in early December. Professional promotions will position Photoplex as a "new full spectrum sunscreen for protection against photosensitivity reactions and photoaging." Consumer labeling does not directly refer to the use of Photoplex in preventing or retarding photoaging. A professional brochure for Photoplex claims that the product "has been shown to provide significantly greater photoprotection against UVA-provoked phototoxicity reactions than conventional sunscreens. Photoplex should prove valuable in helping prevent or reverse photoaging and in managing photosensitive patients." On professional labeling, the product is indicated to provide protection against risks from long-term UVA/UVB exposure such as "sunburn, drug-induced phototoxicity, solar elastosis and keratosis, premature aging of the skin, skin cancer and alteration of immune functions." The product may be positioned as an adjunct to photosensitizing agents such as Ortho's Retin-A. Product labeling claims Photoplex offers "full sun protection: absorbs throughout the UVA spectrum"; "15 times your natural UVB protection"; "water-resistant" and "fragrance-free." The product is indicated for "protection from the acute and long-term risks associated with UVA and UVB light exposure. Photoplex screens out the sun's burning rays to prevent sunburn. The liberal and regular use over the years of this product may help reduce the chances of these harmful effects." Photoplex will be marketed in a 4 oz. bottle with an average wholesale price of $ 7.85. Print ads in professional medical and dermatological journals are slated to break in January. Detailing to physicians will begin in December following the prodct's introduction at the American Academy of Dermatology's annual meeting in early December. Herbert Labs does not plan to run consumer ads. Herbert Labs does not currently have any other suncare products on the market. The company is a former owner of the Eclipse brand sunscreens, which are now owned by Eclipse Labs.

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