Reference Source

Cosmecca Korea Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)

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
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
17-12 Daegeumro196beon-Gil , Daeso-Myeon , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF) verified
Date published
06/24/2016 verified
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. each item verified
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 each item verified
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'. 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

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'.

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

Source

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