Sesderma, SL · 66-41 · SPAIN (Calle Massamagrell 3-5 , Poligono Industrial Rafelbunol , Rafelbunol, Valencia SPAIN)
For Sesderma, SL (Calle Massamagrell 3-5 , Poligono Industrial Rafelbunol , Rafelbunol, Valencia SPAIN), import alert is 66-41; country is SPAIN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Hidraloe Eye Contour Cream | BTSES Anti-wrinkle Moisturizing Gel Cream | Factor G Renew Facial Chin | Mediderma Exoses LB Vitalizing | Silkses Monodose Sterile Skin Moist | Oxyses Mist | Hidraloe Eye Contour Cream | Sucses Peel Step 2 | Meso Cit Timp-2 | Melaspeel K | Mediderma Exoses LB Vitalizing | medi derma SPA PEEL LIGHTENING Chemical Peel | medi derma MESO CIT RU Depigmenting Serum | Silkses Monodose Sterile Skin Moist | Oxyses Mist | Factor G Renew Facial Chin | BTSES Anti-wrinkle Moisturizing Gel Cream | Hidraloe Eye Contour Cream | Sucses Peel Step 2 | Meso Cit Timp-2 | Melaspeel K | Mediderma Exoses LB Vitalizing | Silkses Monodose Sterile Skin Moist | Oxyses Mist | Factor G Renew Facial Chin & Neck | BTSES Anti-wrinkle Moisturizing Gel Cream | Hidraloe Eye Contour Cream | Sucses Peel Step 2 | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing | medi derma SPA PEEL LIGHTENING Chemical Peel | medi derma MESO CIT RU Depigmenting Serum | BTSES Anti-wrinkle Moisturizing Gel Cream | Mediderma Exoses LB Vitalizing | Hidraloe Eye Contour Cream | BTSES Anti-wrinkle Moisturizing Gel Cream | Factor G Renew Facial Chin | Oxyses Mist | Silkses Monodose Sterile Skin Moist | medi derma MESO CIT RU Depigmenting Serum | medi derma SPA PEEL LIGHTENING Chemical Peel | Mediderma Exoses LB Vitalizing | Melaspeel K | Meso Cit Timp-2 | Sucses Peel Step 2; product code is 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 - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 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) | 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 - - 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 - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 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 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 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 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 07/16/2013; address is Calle Massamagrell 3-5 , Poligono Industrial Rafelbunol , Rafelbunol, Valencia SPAIN, verified against its source on 2026-10-01.
- Firm
- Sesderma, SL verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- SPAIN verified
- Address
- Calle Massamagrell 3-5 , Poligono Industrial Rafelbunol , Rafelbunol, Valencia SPAIN verified
- Date published
- 07/16/2013 verified
- Product code
- 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 - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 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) | 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 - - 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 - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 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 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 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 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Hidraloe Eye Contour Cream | BTSES Anti-wrinkle Moisturizing Gel Cream | Factor G Renew Facial Chin | Mediderma Exoses LB Vitalizing | Silkses Monodose Sterile Skin Moist | Oxyses Mist | Hidraloe Eye Contour Cream | Sucses Peel Step 2 | Meso Cit Timp-2 | Melaspeel K | Mediderma Exoses LB Vitalizing | medi derma SPA PEEL LIGHTENING Chemical Peel | medi derma MESO CIT RU Depigmenting Serum | Silkses Monodose Sterile Skin Moist | Oxyses Mist | Factor G Renew Facial Chin | BTSES Anti-wrinkle Moisturizing Gel Cream | Hidraloe Eye Contour Cream | Sucses Peel Step 2 | Meso Cit Timp-2 | Melaspeel K | Mediderma Exoses LB Vitalizing | Silkses Monodose Sterile Skin Moist | Oxyses Mist | Factor G Renew Facial Chin & Neck | BTSES Anti-wrinkle Moisturizing Gel Cream | Hidraloe Eye Contour Cream | Sucses Peel Step 2 | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing | medi derma SPA PEEL LIGHTENING Chemical Peel | medi derma MESO CIT RU Depigmenting Serum | BTSES Anti-wrinkle Moisturizing Gel Cream | Mediderma Exoses LB Vitalizing | Hidraloe Eye Contour Cream | BTSES Anti-wrinkle Moisturizing Gel Cream | Factor G Renew Facial Chin | Oxyses Mist | Silkses Monodose Sterile Skin Moist | medi derma MESO CIT RU Depigmenting Serum | medi derma SPA PEEL LIGHTENING Chemical Peel | Mediderma Exoses LB Vitalizing | Melaspeel K | Meso Cit Timp-2 | Sucses Peel Step 2 each item verified
- FDA notes
- The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. each item verified
What the source says
Sesderma, SL Date Published : 07/16/2013 Calle Massamagrell 3-5 , Poligono Industrial Rafelbunol , Rafelbunol, Valencia SPAIN
— 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 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 07/16/2013 Desc: Hidraloe Eye Contour Cream 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 07/16/2013 Desc: BTSES Anti-wrinkle Moisturizing Gel Cream 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 10/23/2018 Desc: Factor G Renew Facial Chin 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 10/23/2018 Desc: Silkses Monodose Sterile Skin Moist 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 10/23/2018 Desc: Oxyses Mist 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 07/16/2013 Desc: Hidraloe Eye Contour Cream 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Melaspeel K Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/06/2024 Desc: medi derma SPA PEEL LIGHTENING Chemical Peel 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/06/2024 Desc: medi derma MESO CIT RU Depigmenting Serum 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 10/23/2018 Desc: Silkses Monodose Sterile Skin Moist 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 10/23/2018 Desc: Oxyses Mist 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 10/23/2018 Desc: Factor G Renew Facial Chin 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 07/16/2013 Desc: BTSES Anti-wrinkle Moisturizing Gel Cream 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 07/16/2013 Desc: Hidraloe Eye Contour Cream 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Melaspeel K Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 10/23/2018 Desc: Silkses Monodose Sterile Skin Moist 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 10/23/2018 Desc: Oxyses Mist 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 10/23/2018 Desc: Factor G Renew Facial Chin & Neck 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 07/16/2013 Desc: BTSES Anti-wrinkle Moisturizing Gel Cream 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 07/16/2013 Desc: Hidraloe Eye Contour Cream 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/06/2024 Desc: medi derma SPA PEEL LIGHTENING Chemical Peel 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/06/2024 Desc: medi derma MESO CIT RU Depigmenting Serum 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 07/16/2013 Desc: BTSES Anti-wrinkle Moisturizing Gel Cream 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/16/2013 Desc: Hidraloe Eye Contour Cream 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/16/2013 Desc: BTSES Anti-wrinkle Moisturizing Gel Cream 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/23/2018 Desc: Factor G Renew Facial Chin 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/23/2018 Desc: Oxyses Mist 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/23/2018 Desc: Silkses Monodose Sterile Skin Moist 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/06/2024 Desc: medi derma MESO CIT RU Depigmenting Serum 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/06/2024 Desc: medi derma SPA PEEL LIGHTENING Chemical Peel 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Melaspeel K Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.