PRPL DUAL COVER CUSHION NO 21 CRE AM IVORY CUSHION- titanium dioxide, octinoxate, octisalate powder 
Derma&lab Co., Ltd.

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.

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ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 13.19%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

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

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep this product out of the direct rays of the sun. Keep Out of Reach of Children.

DESCRIPTION

Uses:

step1. Apply conceal balm after basic skin care to cover up dark spots and imperfections.

step2. Then apply cushion all over for a fresh-faced finish.

Directions: Dual cover cushion in light fitting texture with micro-jewel extract provides full coverage and luminous radiance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PRPL DUAL COVER CUSHION NO 21 CRE AM IVORY CUSHION 
titanium dioxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71725-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.31 g  in 10 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.67 g  in 10 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.40 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Diisostearyl Malate (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71725-010-021 in 1 CARTON10/01/2017
1NDC:71725-010-0110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2017
Labeler - Derma&lab Co., Ltd. (694725997)
Registrant - Derma&lab Co., Ltd. (694725997)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(71725-010)

Revised: 10/2017
Document Id: 3aa710e9-7f02-4d81-93e3-e811dea4a29e
Set id: 58a3462e-5ef3-4f93-b7e9-d58d000fe414
Version: 1
Effective Time: 20171018
 
Derma&lab Co., Ltd.