Seoul Cosmetics Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Seoul Cosmetics 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 Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | 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 | Soothing & Moisture Aloe Vera 92% Soothing Gel | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Ampoule Cushion (Foundation) | Soothing & Moisture Aloe Vera 92% Soothing Gel | 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 D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G - - -- Makeup Prep(Not For Eyes) | 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 2026-09-16.
- 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 D - 99 Other Makeup Preparation, not for the Eyes, N.E.C., Liquid, Lotion | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G - - -- Makeup Prep(Not For Eyes) | 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
- Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | 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 | Soothing & Moisture Aloe Vera 92% Soothing Gel | Suwall Luxury Oriental Shampoo | Brown Rice Moisture Shampoo | Ampoule Cushion (Foundation) | Soothing & Moisture Aloe Vera 92% Soothing Gel | Ampoule Cushion (Foundation) each item verified
- FDA notes
- 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. | 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.' | 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…” | 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.' | 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) 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 - - 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 - - 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 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 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 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 - - -- Makeup Prep(Not For Eyes) Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 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: 04/30/2025 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 L - - -- Skin Care Prep Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 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: 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: 04/24/2017 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: 04/30/2025 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 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/26/2017 Desc: Soothing & Moisture Aloe Vera 92% Soothing Gel 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…”
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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