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CAMERA READY (SMASHBOX BEAUTY COSMETICS, INC)

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LIQUID 1 TUBE in 1 CARTON (10348-002-01) > 30 mL in 1 TUBE (10348-002-02) Label Information

Complete CAMERA READY Information

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] POLYQUATERNIUM-51 [] ACETYL HEXAPEPTIDE-8 [] TREHALOSE [] ORYZANOL [] OCTYLDODECYL NEOPENTANOATE [] UREA [] POLYGLYCERYL-6 POLYRICINOLEATE [] PROPYLENE GLYCOL LAURATE [] GLYCYRRHETINIC ACID [] TOCOPHERYL ACETATE [] SUCROSE [] GLYCERIN [] SODIUM STEAROYL LACTYLATE [] CAFFEINE [] LINOLEIC ACID [] CHOLESTEROL [] LECITHIN [] SQUALANE [] SODIUM PCA [] ISOPROPYL TITANIUM TRIISOSTEARATE [] PROPYLENE GLYCOL STEARATE [] STEARIC ACID [] POLYSORBATE 20 [] SORBITAN LAURATE [] XANTHAN GUM [] ALUMINUM HYDROXIDE [] SODIUM HYALURONATE [] SILICA [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] CHLORPHENESIN [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA


  • WARNINGS

    WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS.


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.


  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    SMASHBOX CAMERA READY

    5 IN 1

    BEAUTY BALM

    SPF 35


    1.0 FL OZ/ 30 ML




    Smashbox Beauty Cosmetics Inc.

    Culver City, California, 90232

    made in canada

     FOLDING CARTON


     


  • INGREDIENTS AND APPEARANCE
    CAMERA READY  5 IN 1 BEAUTY BALM SPF 35
    octinoxlate, octisalate, oxybenzone, titanium dioxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    WHEAT GERM (UNII: YR3G369F5A)  
    CUCUMBER (UNII: YY7C30VXJT)  
    APPLE (UNII: B423VGH5S9)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
    TREHALOSE (UNII: B8WCK70T7I)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    UREA (UNII: 8W8T17847W)  
    PROPYLENE GLYCOL MONOLAURATE (UNII: M4AW13H75T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10348-002-01 1 in 1 CARTON
    1 NDC:10348-002-02 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/01/2011
    Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aramis Inc. 042918826 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Northtec Bristol 949264774 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Northtec Keystone 618107429 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics, Ltd. 255175580 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics, Ltd 253616536 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Whitman Laboratories Ltd. 216866277 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 manufacture