Reference Source

COSRX INC · 66-41 · KOREA (THE REPUBLIC OF)

For COSRX INC · 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 AHA/BHA Clarifying Treatment Toner | Salicylic Acid Exfoliating Cleanser | Salicylic Acid Exfoliating Cleanser | AHA/BHA Clarifying Treatment Toner; product code is 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 64 X - - 06 Salicylic Acid (Keratolytic) | 65 L - - 99 Protectant N.E.C; date published is 04/20/2016; address is Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
COSRX INC 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
Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) verified
Date published
04/20/2016 verified
Product code
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 64 X - - 06 Salicylic Acid (Keratolytic) | 65 L - - 99 Protectant N.E.C. each item verified
Product
AHA/BHA Clarifying Treatment Toner | Salicylic Acid Exfoliating Cleanser | Salicylic Acid Exfoliating Cleanser | AHA/BHA Clarifying Treatment Toner each item verified
FDA notes
The product appears to be an unapproved new drug as the product labeling and associated product website, www.cosrx.com, include disease claims such as: (product label) 'early prevention of whiteheads and blackheads', and (product website) indicates that the product is intended to 'stimulate cell regeneration'. | The product appears to be an unapproved new drug as the product labeling and associated product website, www.cosrx.com, include disease claims such as: (product label) 'early prevention of whiteheads and blackheads', and (product website) indicates that the product is intended to 'stimulate cell regeneration'. 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

COSRX INC Date Published : 04/20/2016 Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 04/20/2021 Desc: AHA/BHA Clarifying Treatment Toner Notes: The product appears to be an unapproved new drug as the product labeling and associated product website, www.cosrx.com, include disease claims such as: (product label) 'early prevention of whiteheads and blackheads', and (product website) indicates that the product is intended to 'stimulate cell regeneration'. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 05/03/2016 Desc: Salicylic Acid Exfoliating Cleanser 64 X - - 06 Salicylic Acid (Keratolytic) Date Published: 05/03/2016 Desc: Salicylic Acid Exfoliating Cleanser 65 L - - 99 Protectant N.E.C. Date Published: 04/20/2021 Desc: AHA/BHA Clarifying Treatment Toner Notes: The product appears to be an unapproved new drug as the product labeling and associated product website, www.cosrx.com, include disease claims such as: (product label) 'early prevention of whiteheads and blackheads', and (product website) indicates that the product is intended to 'stimulate cell regeneration'.

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

Source

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