Label: DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40- octinoxate, titanium dioxide, octisalate 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 February 11, 2011

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  • ACTIVE INGREDIENT

    active ingredients: octinoxate 7.50% [] titanium dioxide 5.20% [] octisalate 2.00%

  • INACTIVE INGREDIENT

    inactive ingredients: water [] butylene glycol [] c12-15 alkyl benzoate [] cetyl alcohol [] laureth-4 [] chamomilla recutita (matricaria) extract [] saccharomyces cerevisiae extract [] rosmarinus officinalis (rosemary) leaf extract [] chamomilla recutita (matricaria) flower extract [] gentiana lutea (gentian) root extract [] yeast extract\faex\extrait de levure [] oryza sativa (rice) bran extract [] polyethylene [] hordeum vulgare (barley) extract\extrait d'orge [] salicornia herbacea extract [] rosa roxburghii fruit extract [] peg-100 stearate [] citrus unshiu peel extract [] cucumis sativus (cucumber) fruit extract [] plankton extract [] pantethine [] porphyra yezoensis (algae) extract [] helianthus annuus (sunflower) seedcake [] hydrogenated lecithin [] caffeine [] polyglyceryl-3 beeswax [] acetyl glucosamine [] pvp/hexadecene copolymer [] squalane [] polyhydroxystearic acid [] tocopheryl acetate [] isohexadecane [] methicone [] propylene glycol dicaprate [] dipotassium glycyrrhizate [] zeolite [] nylon-12 [] magnesium ascorbyl phosphate [] polysorbate 80 [] hexylene glycol [] caprylyl glycol [] acrylamide/sodium acryloyldimethyltaurate copolymer [] isostearic acid [] calcium chloride [] xanthan gum [] alumina [] disodium edta [] bht [] phenoxyethanol [] zinc oxide (ci 77947) [] iron oxides (ci 77491, ci 77492, ci 77499)

  • 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:


    CLINIQUE

    DERMA WHITE

    CITY BLOCK

    ANTI-POLLUTION SPF 40


    ALL SKIN TYPES


    1 FL OZ LIQ / 30 ML


    CLINIQUE LABS DISTR.
    NEW YORK, NY 10022


     
    FOLDING CARTON

     
  • INGREDIENTS AND APPEARANCE
    DERMA WHITE  CITY BLOCK ANTI-POLLUTION SPF40
    octinoxate, titanium dioxide, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-008-011 in 1 CARTON
    1NDC:49527-008-0230 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2010
    Labeler - CLINIQUE LABS INC (173047747)
    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
    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 Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
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