Label: CAMOUFLAGE CONCEALER SOFT COCOA- 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 July 16, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 11.03%

  • INACTIVE INGREDIENT

    Inactive Ingredients: DIISOSTEARYL MALATE, POLYBUTENE, DIMETHICONE, MICA, PHENYL TRIMETHICONE, IRON OXIDE(Cl 77492), CERESIN, COPERNICIA CERIFERA (CARNAUBA) WAX, SORBITAN SESQUIOLEATE, SILICA, OZOKERITE, IRON OXIDE(Cl 77491), CETYL ETHYLHEXANOATE, CETYL PEG/PPG-10/1 DIMETHICONE, IRON OXIDE(Cl 77499), TOCOPHERYL ACETATE, PROPYLPARABEN, PERFUME, BUTYLPARABEN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: KEEP OUT OF EYES. STOP USING IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

  • DESCRIPTION

    ATTENTION: EVITER TOUT CONTACT AVEC LES YEUX. SUSPENDRE L’UTILISATION EN CAS D’IRRITATION. TENIR HORS DE PORTEE DES ENFANTS.

    ATENCION: EVITE QUE ENTRE EN LOS OJOS. INTERRUMPA SU USO SI SE PRODUCE IRRITACION. MANTENER FUERA DES ALCANCE DE LOS NINOS.

    How to use: APPLY AN ADEQUATE AMOUNT EVENLY OVER ENTIRE FACE.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CAMOUFLAGE CONCEALER SOFT COCOA 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69958-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.55 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69958-080-015 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2015
    Labeler - J2D INTERNATIONAL (689515247)
    Registrant - J2D INTERNATIONAL (689515247)
    Establishment
    NameAddressID/FEIBusiness Operations
    J2D INTERNATIONAL689515247manufacture(69958-080)