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October 30, 1997

HQ 959895

CLA-2 RR:CR:GC 959895ptl


TARIFF NO.: 3304.99.5000

Mr. Joseph Cooper
Vice President, Manufacturing and Distribution Medicis Pharmaceutical Corporation
4343 East Camelback Road
Phoenix, AZ 85108-2700

RE: Reconsideration of New York ruling (NY) A86005, Esoterica Facial, Esoterica Sunscreen, Esoterica Sensitive Skin and Esoterica Regular.

Dear Mr. Cooper:

This is in reference to your letter of August 19, 1996, requesting reconsideration of NY A86005, dated August 9, 1996, which held that the Esoterica line of medicated skin fade creams was classifiable under subheading 3304.99.500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for beauty or make up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations. It is your contention that the products should be classified in heading 3004 HTSUS, which provides for medicaments, because they contain hydroquinone as an active ingredient. We regret the delay in responding.


The products in question are four versions of a fade cream. The versions are identified by the manufacturer as: Esoterica Facial, Esoterica Sunscreen, Esoterica Sensitive Skin, and Esoterica Regular. The products are formulated to deal with dryness, age spots and other discolorations of the skin which come with age. Although each version has slightly different ingredients, the principal components are essentially the same. Each version contains, along with other ingredients, 2 percent by weight photographic hydroquinone, which is the component that causes a reduction of the pigmentation in new skin cells. The new cells replace the older skin cells that continuously slough off from the skin's surface. Since the "newer" cells have less pigmentation, previously dark spots become lighter. Versions of the product which contain sunscreen help prevent dark spots from recurring, but are not intended for use in the prevention of sunburn.


Are Esoterica fade creams classifiable as medicaments?


Merchandise is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) in accordance with the General Rules of Interpretation (GRI). The systematic detail of the HTSUS is such that virtually all goods are classified by application of GRI 1, that is, according to the terms of the headings of the tariff schedule and any relative Section or Chapter Notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI may then be applied in order.

The following subheadings are under consideration:

3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale:

3004.90.90 Other

45 Dermatological agents and local anesthetics

90 Other

3304 Beauty or make-up preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations:

99 Other: Other:

5000 Other.

The products in question are marketed and intended for use as skin creams. They have been specially formulated to address dryness, age spots and discolorations that come with age. The Handbook of Non-prescription Drugs classifies depigmentors as skin care products. The active ingredient, photographic hydroquinone, a depigmentor or skin bleaching agent, is present in each version of the product in a 2 percent concentration. At this level, the Food and Drug Administration has recommended that hydroquinone be available as an "Over the Counter Drug" for nonprescription use.

The concentration level of hydroquinone in the products under consideration does not reach the level at which the product can be considered a medicament. The Physicians Desk Reference classifies products containing 4 percent or more hydroquinone as prescription drugs. Hydroquinone is a bleaching agent. The presence of hydroquinone in the product does not serve either a therapeutic or prophylactic use. As a bleaching agent, hydroquinone acts as a cosmetic ingredient. For these reasons, the product does not act as a dermatological compound and treat a skin ailment or complaint such as eczema. As the product is not a medicament for classification purposes, heading 3004, HTSUS, does not apply.


The Esoterica line of skin care products are properly classified in subheading 3304.99.5000, HTSUS, which provides for beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations: other: other: other.

NY A86005, issued August 9, 1996, is affirmed.


John Durant, Director
Commercial Rulings Division

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