HQ 084102
November 24,1989
CLA-2 CO:R:C:G 084102 JGH
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