Label: PRPL DUAL COVER CUSHION NO 21 CRE AM IVORY CONCEAL BALM- titanium dioxide powder

  • 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 19, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 23.85%

  • INACTIVE INGREDIENT

    Inactive ingredients: Dimethicone, Isotridecyl Isononanoate, Phenyl Trimethicone, Mica (CI 77019), Barium Sulfate, Boron Nitride, Paraffin, Pentaerythrityl Tetraethylhexanoate, Caprylic/Capric Triglyceride, Diglyceryl Sebacate/Isopalmitate, Alumina, VP/Hexadecene Copolymer, Iron Oxides (CI 77492), Phytosteryl Macadamiate, Sorbitan Isostearate, Cera Microcristallina, Polyethylene, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Fragrance(Parfum), Iron Oxides (CI 77499), Magnesium Myristate, Glycyrrhiza Glabra (Licorice) Root Extract, Caprylyl Glycol, Glyceryl Caprylate, Adenosine, Butylene Glycol, Water, Oryza Sativa (Rice) Bran Oil, Diamond powder, Hydrolyzed Silk, Salix Alba (Willow) Bark Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Tocopheryl Acetate Polymethylsilsesquioxane, Pearl Extract, Helianthus Annuus (Sunflower) Seed Oil, Xylitylglucoside, Anhydroxylitol, Silica, Methyl Methacrylate Crosspolymer, Silica Dimethyl Silylate, Vinyl Dimethicone/Methicone Silsesquioxane, Crosspolymer, HDI/Trimethylol Hexyllactone Crosspolymer, Xylitol, Glycerin, Lupinus Albus Seed Extract, Fucus Vesiculosus Extract, Vanilla Tahitensis Fruit Extract, Ascophyllum Nodosum Extract, Pelvetia Canaliculata Extract, Phenoxyethanol, Tocopherol, 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

  • INGREDIENTS AND APPEARANCE
    PRPL DUAL COVER CUSHION NO 21 CRE AM IVORY CONCEAL BALM 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71725-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.43 g  in 6 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Isotridecyl Isononanoate (UNII: WEF51750MT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71725-020-021 in 1 CARTON10/01/2017
    1NDC:71725-020-016 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(71725-020)