OT:RR:NC:N3:140
Brennan O'Gorman
Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP
599 Lexington Avenue, Floor 36
New York, NY 10022
RE: The country of origin of Dermasil® Dry Skin Treatment Body Lotion
Dear Mr. O'Gorman:
In your letter dated July 15, 2025, on behalf of Fantasia Accessories Ltd., you requested a country of origin
and marking ruling
Dermasil® Dry Skin Treatment Body Lotion is described as an over the counter (OTC) body lotion
containing the active ingredient dimethicone. You indicate that it is specially formulated to create a barrier on
the skin to lock in moisture and protect against irritation.
In addition to dimethicone, other raw materials used to produce the body lotion include emulsifiers,
preservatives, thickeners, oils, stabilizers, and moisturizing agents. These ingredients are sourced from
various countries and will be sent to either Malaysia or Vietnam.
In Malaysia or Vietnam, the ingredients will be weighed, emulsified, homogenized, and blended under
controlled conditions to produce a stable bulk using a mixing machine (emulsifier). This process includes
heating oil and water phases separately, then combining with high shear mixing operations. Preservatives and
other ingredients will be added in a cooled-down phase. The formulation will then be bulk tested for pH,
microbial content, and stability. After testing, the bulk formulation will then be sent from Malaysia or
Vietnam to China where it will be filled into retail containers, affixed with retail labels, and packaged in
cartons for exportation to the United States. All packaging materials (bottles, caps, cartons, and cardboard)
originate in China.
Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every
article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly,
indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to
indicate to the ultimate purchaser in the United States, the English name of the country of origin of the
article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to
know by an inspection of the marking on the imported goods the country of which the goods is the product.
The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by
knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should
influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940).
Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the
country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP
Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or
growth of any article of foreign origin entering the United States. Further work or material added to an article
in another country must effect a substantial transformation in order to render such other country the “country
of origin” within the meaning of the marking laws and regulations.
A substantial transformation occurs when, as a result of manufacturing process, a new and different article
emerges, having a distinct name, character or use, which is different from that originally possessed by the
article or material before being subjected to the manufacturing process. See United States v.
Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940).
We have determined that the production process in Malaysia or Vietnam results in a substantial
transformation. Therefore, it is our opinion that the country of origin of the Dermasil® Dry Skin Treatment
Body Lotion will be Malaysia or Vietnam, based on the country where the production process occurs.
We find that the proposed marking of the body lotion as "Product of Malaysia" or "Product of Vietnam" if
printed legibly, clearly, and in a conspicuous place would be considered an acceptable method of marking
and would meet the country of origin marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134. Since
the body lotion is incapable of being marked, it is excepted (19 CFR Section 134.32(a)). Accordingly
marking the outermost container in which the body lotion is imported and sold to the ultimate purchaser is an
acceptable country of origin marking.
In your request, you asked whether the body lotion will be subject to the additional duties imposed upon
Chinese goods pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, and Section 301 of the Trade Act of
1974. Currently, these duties only apply to articles that are products of the People’s Republic of China.
Therefore, the body lotion will not be subject to the additional duties imposed by U.S. Note 2(u) to
Subchapter III, Chapter 99, and Section 301.
You also asked whether the body lotion will be subject to the “Reciprocal Tariffs.” Effective April 5, 2025,
Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either
the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions
covering exceptions to the reciprocal tariffs. At this time products from all countries will be subject to an
additional 10 percent ad valorem rate of duty.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.gov.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Merari Ortiz at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division