SESDERMA SL · 66-41 · SPAIN (Pol Industrial La Murta , Avinguda Molins 12 , Pucol, Valencia SPAIN)

Product code, Product and FDA notes

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 - - 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: 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 - - 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: 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 - - 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: 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 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: 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)].