Label: BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream

  • 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 June 7, 2012

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS:

    AVOBENZONE 2.00%

    HOMOSALATE 5.00%

    OCTINOXATE 7.50%

    OXYBENZONE 5.00%

  • PURPOSE

    SUNSCREEN

  • USE

    HELPS PREVENT SUNBURN

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    For sunscreen use:

        * apply liberally 15 minutes before sun exposure
        * reapply at least every two hours
        * use a water resistant sunscreen if swimming or sweating
        * Sun Protection Measures.
          Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
              o limit time in the sun, especially from 10 a.m.–2 p.m.
              o wear long-sleeved shirts, pants, hats and sunglasses
        * children under 6 months of age: ask a doctor

  • INACTIVE INGREDIENTS

    INGREDIENTS: WATER\AQUA\EAU [] GLYCERIN [] PEG-4 DIHEPTANOATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] CETEARYL ALCOHOL [] CETYL ALCOHOL [] GLYCERYL STEARATE [] HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] SQUALANE [] ETHYLHEXYLGLYCERIN [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] ROSMARINUS OFFICINALIS (ROSEMARY) [] ANTHEMIS NOBILIS (CHAMOMILE) [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] ANGELICA ARCHANGELICA SEED OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] PHENYL TRIMETHICONE [] DIMETHICONE [] LECITHIN [] BUTYLENE GLYCOL [] PEG-12 DIMETHICONE [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] ASTROCARYUM MURUMURU SEED BUTTER [] SORBITAN STEARATE [] POLYSORBATE 60 [] PEG-40 STEARATE [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] ALUMINA [] PROPYLENE GLYCOL STEARATE [] POLYSORBATE 20 [] ACETYL HEXAPEPTIDE-8 [] SORBITAN LAURATE [] PROPYLENE GLYCOL LAURATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] POTASSIUM SORBATE [] CHLORPHENESIN [] PHENOXYETHANOL [] LIMONENE [] CITRONELLOL [] GERANIOL [] LINALOOL [] CITRAL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

  • OTHER INFORMATION

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    BOBBI BROWN

    EXTRA

    SPF 25 TINTED MOISTURIZING BALM

    BROAD SPECTRUM SPF 25



    NET WT./ POIDS  NT 1 OZ/ 30 ML



    DIST. BOBBI BROWN PROFESSIONAL COSMETICS

    NY, NY 10022

    FOLDING CARTON


  • INGREDIENTS AND APPEARANCE
    BOBBI BROWN EXTRA  TINTED MOISTURIZING BALM SPF 25
    octinoxate, homosalate, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-814
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ROSEMARY (UNII: IJ67X351P9)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    ANGELICA SEED OIL (UNII: 67IO7RRV7A)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64141-814-011 in 1 CARTON
    1NDC:64141-814-0230 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2004
    Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol959338336manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone943871157manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.244669714manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center (PALC)078364654repack, relabel
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