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

For Cosmecca Korea 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 DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR TONER | SRB 3 Lighting White Nutri-Cream | DR. MELAXIN EXOSOME REPAIR TONER | AHA BHA PHA 30 DAYS MIRACLE SERUM | Repair Serum-Ginseng Snail Mucin (Face Serum) | DR. MELAXIN EXOSOME REPAIR MASK PACK | SRB 3 Lighting White Sun Cream | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR MASK PACK | SRB 3 Lighting White Nutri-Cream | SRB 3 Lighting White Sun Cream | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR TONER | SRB 3 Lighting White Sun Cream | SRB 3 Lighting White Nutri-Cream | AHA BHA PHA 30 DAYS MIRACLE SERUM; product code is 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. | 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/24/2016; address is 17-12 Daegeumro196beon-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Cosmecca Korea 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:** 17-12 Daegeumro196beon-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 06/24/2016 _(verified: appears in the quote below)_
- **Product code:** 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. | 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR TONER | SRB 3 Lighting White Nutri-Cream | DR. MELAXIN EXOSOME REPAIR TONER | AHA BHA PHA 30 DAYS MIRACLE SERUM | Repair Serum-Ginseng Snail Mucin (Face Serum) | DR. MELAXIN EXOSOME REPAIR MASK PACK | SRB 3 Lighting White Sun Cream | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR MASK PACK | SRB 3 Lighting White Nutri-Cream | SRB 3 Lighting White Sun Cream | DR. MELAXIN EXOSOME REPAIR TONER | DR. MELAXIN EXOSOME REPAIR MASK PACK | DR. MELAXIN EXOSOME REPAIR TONER | SRB 3 Lighting White Sun Cream | SRB 3 Lighting White Nutri-Cream | AHA BHA PHA 30 DAYS MIRACLE SERUM _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): Label - 'Brightening; Skin soothing and strengthen barrier; stabilizing the skin turnover cycle'; Website - 'Treat and sooth sensitive and breakout-prone skin; This will aid in... promoting cell turnover which in turn help fade dark spots'. | The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): Label - 'Brightening; Skin soothing and strengthen barrier; stabilizing the skin turnover cycle'; Website - 'Treat and sooth sensitive and breakout-prone skin; This will aid in... promoting cell turnover which in turn help fade dark spots'. _(verified: each item appears in the quote below)_

## What the source says

> Cosmecca Korea Co., Ltd. Date Published : 06/24/2016 17-12 Daegeumro196beon-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF) 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 06/24/2016 Desc: SRB 3 Lighting White Nutri-Cream 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 02/10/2021 Desc: AHA BHA PHA 30 DAYS MIRACLE SERUM Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): Label - 'Brightening; Skin soothing and strengthen barrier; stabilizing the skin turnover cycle'; Website - 'Treat and sooth sensitive and breakout-prone skin; This will aid in... promoting cell turnover which in turn help fade dark spots'. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/30/2020 Desc: Repair Serum-Ginseng Snail Mucin (Face Serum) 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 06/24/2016 Desc: SRB 3 Lighting White Sun Cream 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 L - - 09 Skin Fresheners (Skin Care Preparations) Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 06/24/2016 Desc: SRB 3 Lighting White Nutri-Cream 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 06/24/2016 Desc: SRB 3 Lighting White Sun Cream 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR MASK PACK 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 06/07/2024 Desc: DR. MELAXIN EXOSOME REPAIR TONER 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. Date Published: 06/24/2016 Desc: SRB 3 Lighting White Sun Cream 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. Date Published: 06/24/2016 Desc: SRB 3 Lighting White Nutri-Cream 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/10/2021 Desc: AHA BHA PHA 30 DAYS MIRACLE SERUM Notes: The product appears to be an unapproved new drug as the product's label and promotional website include claims such as (not an all-inclusive list): Label - 'Brightening; Skin soothing and strengthen barrier; stabilizing the skin turnover cycle'; Website - 'Treat and sooth sensitive and breakout-prone skin; This will aid in... promoting cell turnover which in turn help fade dark spots'.

## 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/).