HQ 084102: Classification of a Sunscreen Agent

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                                       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.
























                                          -2-


            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.



















                                          -3-


            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.























                                          -4-


                 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
                                        Commercial Rulings Division










































            6 cc: A.D.,N.Y.,Seaport
            J. Hurley library/peh
            084102