NDC | 71252-100-01, 71252-100-02 |
Set ID | 80e4f4fd-16d2-4c9f-bf4b-e19dce87d9e5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cdpharmtec Co.,ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, Butylene Glycol,Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate,Arbutin,Cetearyl Alcohol,Glycerin,Glyceryl Stearate,Cetearyl Olivate,Polysorbate 60, Sorbitan Olivate,PEG-100 Stearate,Sorbitan Stearate,Sodium Hydroxide,Dimethicone, Methyl Methacrylate Crosspolymer, VP/Hexadecene Copolymer, Polyacrylate-13, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Polyisobutene, Ceramide NP, Human Stem Cell Conditioned Media, Disodium EDTA, 1,2-Hexanediol, Tocopheryl Acetate, Phospholipids, Adenosine, Polysorbate 20, BHT, Phytosphingosine, Sorbitan Isostearate, CI 17200
- PURPOSE
- WARNINGS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUEENS ROSE WHOLE IN ONE SUNBLOCK
octinoxate, octisalate, ensulizole, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71252-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.75 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 50 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2.0 g in 50 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71252-100-02 1 in 1 CARTON 03/02/2017 1 NDC:71252-100-01 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/02/2017 Labeler - Cdpharmtec Co.,ltd (694209262) Registrant - Cdpharmtec Co.,ltd (694209262) Establishment Name Address ID/FEI Business Operations Cdpharmtec Co.,ltd 694209262 relabel(71252-100) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71252-100)