Seoul Cosmetics Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Seoul Cosmetics Co., Ltd., import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Brown Rice Moisture Shampoo | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Suwall Luxury Oriental Shampoo | Soothing & Moisture Aloe Vera 92% Soothing Gel | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Soothing & Moisture Aloe Vera 92% Soothing Gel | Soothing & Moisture Aloe Vera 92% Soothing Gel | Ampoule Cushion (Foundation) | Soothing & Moisture Aloe Vera 92% Soothing Gel | Brown Rice Moisture Shampoo | Soothing & Moisture Aloe Vera 92% Soothing Gel | Suwall Luxury Oriental Shampoo | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation); product code is 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 G - - -- Makeup Prep(Not For Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 L - - -- Skin Care Prep | 53 L - - -- Skin Care Prep | 65 L - - 99 Protectant N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 04/24/2017; address is 12 Namdongdongro63beon-Gil , Namdong District, Incheon KOREA (THE REPUBLIC OF), verified against its source on 2026-10-01.
- Firm
- Seoul Cosmetics 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
- 12 Namdongdongro63beon-Gil , Namdong District, Incheon KOREA (THE REPUBLIC OF) verified
- Date published
- 04/24/2017 verified
- Product code
- 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 G - - -- Makeup Prep(Not For Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 L - - -- Skin Care Prep | 53 L - - -- Skin Care Prep | 65 L - - 99 Protectant N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. each item verified
- Product
- Brown Rice Moisture Shampoo | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Suwall Luxury Oriental Shampoo | Soothing & Moisture Aloe Vera 92% Soothing Gel | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) | Soothing & Moisture Aloe Vera 92% Soothing Gel | Soothing & Moisture Aloe Vera 92% Soothing Gel | Ampoule Cushion (Foundation) | Soothing & Moisture Aloe Vera 92% Soothing Gel | Brown Rice Moisture Shampoo | Soothing & Moisture Aloe Vera 92% Soothing Gel | Suwall Luxury Oriental Shampoo | Ampoule Cushion (Foundation) | Ampoule Cushion (Foundation) each item verified
- FDA notes
- The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' | Drug claims made on product labels and company websites. | The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' | Drug claims made on product labels and company websites. | 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…” | The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' | Drug claims made on product labels and company websites. | 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…” each item verified
What the source says
Seoul Cosmetics Co., Ltd. Date Published : 04/24/2017 12 Namdongdongro63beon-Gil , Namdong District, Incheon KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-24
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 04/24/2017 Desc: Brown Rice Moisture Shampoo Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 05/09/2017 Desc: Suwall Luxury Oriental Shampoo Notes: Drug claims made on product labels and company websites. 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 04/24/2017 Desc: Brown Rice Moisture Shampoo Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 05/09/2017 Desc: Suwall Luxury Oriental Shampoo Notes: Drug claims made on product labels and company websites. 53 G - - -- Makeup Prep(Not For Eyes) Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 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 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 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 53 L - - -- Skin Care Prep Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 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…” 65 L - - 99 Protectant N.E.C. Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/24/2017 Desc: Brown Rice Moisture Shampoo Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (Label) 'It prevents generation of dandruff and inflammation by helping anti-inflammation and anti-fungal effects of your scalp'; and 'It stimulates blood circulation so that it will prevent hair loss and promote hair growth.' (Website) 'Helps with the anti-inflammation and anti-bacterial action of the scalp to inhibit the growth of dandruff and inflammation.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/09/2017 Desc: Suwall Luxury Oriental Shampoo Notes: Drug claims made on product labels and company websites. 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…”
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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