FOUNDATION SOFT COCOA (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) LIQUID [J2D INTERNATIONAL]

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FOUNDATION SOFT COCOA (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) LIQUID [J2D INTERNATIONAL]
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NDC 69958-040-01
Set ID 343c7cca-6acc-4265-8023-dcf368b378a4
Category HUMAN OTC DRUG LABEL
Packager J2D INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredient: TITANIUM DIOXIDE 7.84%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, ZINC OXIDE 1.02%

  • INACTIVE INGREDIENT

    Inactive Ingredients: WATER, MINERAL OIL, OCTYLDODECANOL, CETYL ETHYLHEXANOATE, GLYCERIN, DIMETHICONE, MICA, CETYL PEG/PPG-10/1 DIMETHICONE, IRON OXIDE(Cl 77492), BEESWAX, ISOAMYL p-METHOXYCINNAMATE, IRON OXIDE(Cl 77491), SORBITAN SESQUIOLEATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM CHLORIDE, IRON OXIDE(Cl 77499), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, PERFUME, ALLANTOIN, MORUS ALBA BARK EXTRACT, PORTULACA OLERACEA EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, DISODIUM EDTA

  • 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
    FOUNDATION SOFT COCOA 
    titanium dioxide, octinoxate, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69958-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.90 g  in 37 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.85 g  in 37 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.37 g  in 37 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69958-040-0137 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(69958-040)
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