# Seoul Cosmetic co., Ltd · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 15 Namdongdongro63beon-gil , Namdong-gu , Namdong, Incheon KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/30/2025 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **Product:** Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) _(verified: each item appears in the quote below)_
- **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…” _(verified: each item appears in the quote below)_

## 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…”

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).