Reference Source

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

For Seoul Cosmetic co., Ltd · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation); product code is 53 G D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 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 2026-09-16.

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 D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 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) 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 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 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…”

accessdata.fda.gov, retrieved 2026-09-15

Source

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