Label: VITAMIN E LIP CONDITIONER SPF 15- octinoxate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL

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 April 29, 2010

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  • ACTIVE INGREDIENT


    ACTIVE INGREDIENTS: OCTINOXATE 7.5% [] OCTISALATE 3.5%
  • WARNINGS

    WARNING: STOP USE IF IRRITATION OCCURS

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    JO MALONE
    LONDON

    VITAMIN E LIP CONDITIONER
    SPF 15

    0.5 FL OZ LIQ/ 15 ML


    DEVELOPED BY JO MALONE
    IN LONDON, ENGLAND

    JO MALONE LTD. DISTR.
    LONDON, ENGLAND
    W1K 3BQ
    FOLDING CARTON






  • INGREDIENTS AND APPEARANCE
    VITAMIN E LIP CONDITIONER  SPF 15
    octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62874-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5   in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62874-995-011 in 1 CARTON
    1NDC:62874-995-0215 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2003
    Labeler - JO MALONE LTD, Distr. (347366049)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1110482184manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636manufacture, label, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture