Reference Source

Seoul Cosmetic co., Ltd · 66-41 · KOREA (THE REPUBLIC OF)

For Seoul Cosmetic co., Ltd, import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation); product code is 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 L - - -- Skin Care Prep | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 04/30/2025; address is 15 Namdongdongro63beon-gil , Namdong-gu , Namdong, Incheon KOREA (THE REPUBLIC OF), verified against its source on 2026-10-01.

Firm
Seoul Cosmetic co., Ltd verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
KOREA (THE REPUBLIC OF) verified
Address
15 Namdongdongro63beon-gil , Namdong-gu , Namdong, Incheon KOREA (THE REPUBLIC OF) verified
Date published
04/30/2025 verified
Product code
53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 L - - -- Skin Care Prep | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. each item verified
Product
Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) each item verified
FDA notes
This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Seoul Cosmetic co., Ltd Date Published : 04/30/2025 15 Namdongdongro63beon-gil , Namdong-gu , Namdong, Incheon KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-24

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) Date Published: 04/30/2025 Desc: Ampoule Cushion (Foundation) Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” 53 G D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion Date Published: 04/30/2025 Desc: Ampoule Cushion (Foundation) Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” 53 L - - -- Skin Care Prep Date Published: 04/30/2025 Desc: Ampoule Cushion (Foundation) Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/30/2025 Desc: Ampoule Cushion (Foundation) Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…” 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 04/30/2025 Desc: Ampoule Cushion (Foundation) Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling includes statements such as (not an all-inclusive list): “…UV Blocking”, “…SPF50+”, “…protects your skin from the Sun…”

— all from accessdata.fda.gov, retrieved 2026-09-24

Source

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