Label: BOBBI BROWN BRIGHTENING PROTECTIVE FACE BASE UV SPF 50- homosalate, octisalate, avobenzone and oxybenzone cream

  • NDC Code(s): 64141-005-01, 64141-005-02
  • 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 07/10

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: HOMOSALATE 5.00% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] OXYBENZONE 3.00%

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  • WHEN USING

    DIRECTIONS: SMOOTH ON SKIN BEFORE OR AFTER MAKEUP

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  • WARNINGS

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

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  • PRINCIPAL DISPLAY PANEL

    BOBBI BROWN

    BRIGHTENING

    SPF 50 UV

    PROTECTIVE FACE BASE

    1.7 OZ/50 ML

    DIST. BOBBI BROWN PROFESSIONAL COSMETICS

    NEW YORK, NY 10022

    FOLDING CARTON


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  • INGREDIENTS AND APPEARANCE
    BOBBI BROWN BRIGHTENING PROTECTIVE FACE BASE  UV SPF 50
    homosalate, octisalate, avobenzone, oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64141-005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOMOSALATE (HOMOSALATE) HOMOSALATE 5.0 mL  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 5.0 mL  in 100 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 3.0 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64141-005-01 1 in 1 CARTON
    1 NDC:64141-005-02 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/13/2010
    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
    PADC 1 110482184 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
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