# COSRX INC · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/20/2016 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **Product:** AHA/BHA Clarifying Treatment Toner | Salicylic Acid Exfoliating Cleanser | Salicylic Acid Exfoliating Cleanser | AHA/BHA Clarifying Treatment Toner _(verified: each item appears in the quote below)_
- **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'. _(verified: each item appears in the quote below)_

## 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'.

## 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/).