Label: EXTRA REPAIR MOISTURING BALM SPF 25- octinoxate, homosalate, oxybenzone and avobenzone cream

  • NDC Code(s): 64141-112-01, 64141-112-02
  • Packager: Bobbi Brown Professional Cosmetics Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] HOMOSALATE 5.00% [] OXYBENZONE 3.00% [] AVOBENZONE 2.00%

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER [] C12-15 ALKYL ETHYLHEXANOATE [] BUTYLOCTYL SALICYLATE [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PROPANEDIOL [] CETYL ALCOHOL [] CETEARYL ALCOHOL [] GLYCERYL STEARATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] POLYACRYLAMIDE [] TOCOPHERYL ACETATE [] NEOPENTYL GLYCOL DIHEPTANOATE [] SUCROSE [] POLYETHYLENE [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] SALVIA SCLAREA (CLARY) EXTRACT [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] PISUM SATIVUM (PEA) EXTRACT [] BAMBUSA VULGARIS (BAMBOO) EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] ANTHEMIS NOBILIS (CHAMOMILE) [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] CHOLESTEROL [] LINOLEIC ACID [] CAFFEINE [] ACETYL HEXAPEPTIDE-8 [] SORBITAN STEARATE [] PEG-40 STEARATE [] C13-14 ISOPARAFFIN [] CAPRYLYL GLYCOL [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] LAURETH-7 [] GLUCOSAMINE HCL [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] SODIUM HYDROXIDE [] HEXYLENE GLYCOL [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] GERANIOL [] LINALOOL [] LIMONENE [] CITRAL [] CITRONELLOL [] PHENOXYETHANOL

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  • WARNINGS

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

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  • PRINCIPAL DISPLAY PANEL


    BOBBI BROWN


    EXTRA

    REPAIR MOISTURIZING

    BALM SPF 25



    1.7 OZ./50 ML



    DISTR. BOBBI BROWN PROFESSIONAL COSMETICS

    NEW YORK, NY 10022

    FOLDING CARTON

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  • INGREDIENTS AND APPEARANCE
    EXTRA  REPAIR MOISTURING BALM SPF 25
    octinoxate, homosalate, oxybenzone, avobenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-112
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SUCROSE (UNII: C151H8M554)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    PEA (UNII: W4X7H8GYFM)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    ROSEMARY (UNII: IJ67X351P9)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
    CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    WHEY (UNII: 8617Z5FMF6)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64141-112-01 1 in 1 CARTON
    1 NDC:64141-112-02 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/16/2011
    Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
    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
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