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HQ 084102


November 24,1989

CLA-2 CO:R:C:G 084102 JGH

CATEGORY: CLASSIFICATION

TARIFF NO.: 2918.90.4000

Kenneth R. Paley, Esq..
Sharretts, Paley, Carter & Blauvelt
1707 L St. N.W.
Washington, D.C. 20036

RE: Classification of a Sunscreen Agent

Dear Mr. Paley:

This is in reference to your submissions in regard to the classification of Parsol MCX under the Harmonized Tariff Schedule of the United States (HTSUS).

FACTS:

Parsol MCX (2-Ethylhexyl p-methoxycinnamate) is described as a sunscreen active ingredient: a chemical used in products designed for sunburn protection, to aid in the prevention of premature aging, wrinkling of the skin, and possibly skin cancer caused by overexposure to the sun. Used in recommended formulations, it is said to absorb up to 98.8 percent of ultraviolet light rays before they reach the skin.

ISSUE:

Whether the sunscreen agent Parsol MCX is classified in the provision for other carboxylic acids: drugs, in subheading 2918.90.3000, HTSUS, or other aromatic carboxylic acids in 2918.90.4000, HTSUS.

LAW AND ANALYSIS:

Classification under the HTSUS is governed by the General Rules of Interpretation (GRI's). GRI 1 provides that classification is determined first in accordance with the headings and any relative Section and Chapter Notes. The Explanatory Notes to the HTSUS are referred to for guidance in interpreting the provisions of the HTSUS on the international level.

According to technical authorities, sunburn is caused by certain wavelengths of ultraviolet (UV) radiation striking the skin. The ultraviolet light alters the keratinocytes in the basal layer of the epidermis. A slight alteration results in erythema, and severe alteration causes bullae to form from the fluid collected in the epidermis. To produce a suntan, ultraviolet light stimulates the melanocytes in the germinating layer to generate more melanin and oxidizes melanin already in the epidermis. Both of these processes serve as protective mechanisms by diffusing and absorbing additional UV radiation.

In support of the argument that Parsol MCX is a drug, evidence was submitted to show that it is so regarded by the Food and Drug Administration (FDA), as well as other authorities, including the American Pharmaceutical Association, American Medical Association, Physicians' Desk Reference, and American Society of Hospital Pharmacists. In 21 CFR 352, Federal Register Vol 43, No. 166, August 25,1976, it was stated that many products used for tanning had been regarded by the FDA as cosmetics, but this opinion had been changed, and now the FDA considers such products as drugs. The active ingredients, it was added, reduce by varying amounts the solar radiation absorbed by the skin and the response and extent of the erythemal reaction produced. "Indeed, these products affect the structure and function of the body by screening, reflecting or scattering the harmful, burning rays of the sun."

The primary uses of sunscreens are to prevent sunburn and aid in the development of a tan. Secondarily, they serve to protect exposed areas of the body in susceptible individuals from the long-term hazards of skin cancer and premature aging. A sunscreen may act either chemically or physically.

The majority of suncreens commonly used in the OTC market act chemically to absorb specific portions of the UV spectrum. Physical sunscreens act by providing an actual physical barrier to solar radiation. Instead of absorbing UV light, these agents scatter and reflect such light, thereby reducing the likelihood of sunburn. Purchasers of sunscreen products are said not to have a pathological condition but a desire to acquire a suntan and prevent a painful sunburn. One way for women to avoid over-exposure to the skin, it was noted, is through the use heavy opaque makeup.

In the HTSUS the term "drugs" is not defined, as it was in the Tariff Schedules of the United States (TSUS), where in headnote 2, part 3, Schedule 4, TSUS, drugs were defined as those substances having therapeutic or medicinal properties. In the HTSUS, the term used is "medicaments", and in the headings where it appears, the products covered are those which are said to be medicinal preparations for use in the internal or external treatment or prevention of human or animal ailments.

It is argued that since these suncreen agents are used in sunscreen or suntan preparations, which are regarded as skin care preparations in the HTSUS, they are not classifiable as drugs. However, even though a chemical is used as an active ingredient in a product not considered a drug under the HTSUS, this does not mean that it is not an active drug ingredient. The Explanatory Notes to heading 3003 point out, for example, that acne preparations are regarded as cosmetic products for classification purposes where "they do not contain sufficiently high levels of active ingredients to be regarded as having primary therapeutic or prophylatic effect..." Therefore, even though the suntan preparation may be classified as a cosmetic, an active ingredient it might contain could be considered a drug or medicament for classification purposes. Classification, therefore, of the finished product as a drug or cosmetic would depend on the nature of the active ingredient present and the amount of it in the finished product.

Based on an evaluation of technical literature submitted, it is concluded that Parsol MCX is therapeutic in nature, and, therefore, it is classifiable under the provision for other aromatic carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids: drugs,in subheading 2918.90.3000, HTSUS.

HOLDING:

Parsol MCX is classifiable in subheading 2918.90.3000, HTSUS. The rate of duty is 6.8 percent ad valorem.

Sincerely,

John Durant, Director

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