Label: PRPL DUAL COVER CUSHION NO 21 CRE AM IVORY CUSHION- titanium dioxide, octinoxate, octisalate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 71725-010-01, 71725-010-02 - Packager: Derma&lab Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 18, 2017
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, Diisostearyl Malate, Cyclopentasiloxane, Glycerin, Phenyl Trimethicone , Cyclohexasiloxane, Butylene Glycol, Trimethylsiloxysilicate, LaurylDimethiconePEG-9 Polydimethylsiloxyethyl, Niacinamide, Pentylene, Glycol, Methyl Methacrylate Crosspolymer, Polypropylsilsesquioxane, Iron Oxides (CI 77492), Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Alumina, Aluminum Hydroxide, Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Silica, Silica Dimethyl Silylate, CrosspolymerVinyl Dimethicone/Methicone Silsesquioxane, HDI/Trimethylol Hexyllactone, Crosspolymer, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Diamond powder, Hydrolyzed Silk, Oryza Sativa (Rice) Bran Oil, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Polymethylsilsesquioxane, Pearl Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Xylitylglucoside, Anhydroxylitol, Xylitol, Lupinus Albus Seed Extract, Fucus Vesiculosus Extract, Vanilla Tahitensis Fruit Extract, Ascophyllum Nodosum Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Pelvetia Canaliculata Extract, Platinum Powder
- PURPOSE
- WARNINGS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRPL DUAL COVER CUSHION NO 21 CRE AM IVORY CUSHION
titanium dioxide, octinoxate, octisalate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71725-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.31 g in 10 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 0.67 g in 10 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.40 g in 10 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Diisostearyl Malate (UNII: QBS8A3XZGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71725-010-02 1 in 1 CARTON 10/01/2017 1 NDC:71725-010-01 10 g in 1 CONTAINER; 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 10/01/2017 Labeler - Derma&lab Co., Ltd. (694725997) Registrant - Derma&lab Co., Ltd. (694725997) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(71725-010)
