Label: SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION- oxybenzone, octisalate, 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 28, 2011

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  • ACTIVE INGREDIENT

    active ingredients: octisalate 5.00% [] oxybenzone 5.00% [] avobenzone 3.00%

  • INACTIVE INGREDIENT

    inactive ingredients: water\aqua\eau [] dimethicone [] butyloctyl salicylate [] polyester-8 [] butylene glycol [] cetearyl alcohol [] silica [] glyceryl stearate [] peg-100 stearate [] glycerin [] hydrogenated lecithin [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] padina pavonica (thallus) extract [] petrolatum [] isopropyl ppg-2-isodeceth-7 carboxylate [] sea whip extract [] jojoba esters [] adenosine phosphate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] lauroyl lysine [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] sucrose [] micrococcus lysate [] astrocaryum murumuru seed butter [] cetearyl glucoside [] laurdimonium hydroxypropyl hydrolyzed soy protein [] dimethiconol [] lecithin [] algae extract [] hexylene glycol [] ethylhexyl stearate [] ethylhexyl palmitate [] propylene glycol dicaprate [] chamomilla recutita (matricaria) [] caprylyl glycol [] isohexadecane [] polyethylene [] ethylhexylglycerin [] zeolite [] behenyl alcohol [] polysorbate 80 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] acrylates/c10-30 alkyl acrylate crosspolymer [] tromethamine [] arginine ferulate [] decarboxy carnosine hcl [] xanthan gum [] sodium chloride [] potassium sulfate [] disodium edta [] phenoxyethanol

  • WARNINGS

    warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:



    CLINIQUE

    SUPERDEFENSE SPF

    AGE DEFENSE MOISTURIZER

    SPF 25

    DRY COMBINATION SKIN



    NT WT. 1.7 OZ./50 ML



    CLINIQUE LABORATORIES INC, DISTR

    NEW YORK, NY 10022

    FOLDING CARTON



  • INGREDIENTS AND APPEARANCE
    SUPER DEFENSE  SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION
    oxybenzone, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-707
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
    ECHINACEA PALLIDA (UNII: 904CK3270L)  
    ROSEMARY (UNII: IJ67X351P9)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    TREHALOSE (UNII: B8WCK70T7I)  
    CREATINE (UNII: MU72812GK0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADENOSINE PHOSPHATE DISODIUM (UNII: T1WZ11DSRN)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SULFATE (UNII: 1K573LC5TV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SUCROSE (UNII: C151H8M554)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-707-011 in 1 CARTON
    1NDC:49527-707-0250 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2008
    Labeler - CLINIQUE LABORATORIES 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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