SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN (OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [CLINIQUE LABORATORIES INC]

SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN (OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [CLINIQUE LABORATORIES INC]
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NDC 49527-708-01, 49527-708-02
Set ID e5069e15-09c0-4eb1-8030-bbe65e5a4a76
Category HUMAN OTC DRUG LABEL
Packager CLINIQUE LABORATORIES INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

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

  • INACTIVE INGREDIENT


    inactive ingredients: water [] dimethicone [] petrolatum [] butylene glycol [] butyloctyl salicylate [] polyglyceryl-2 triisostearate [] caprylic/capric/myristic/stearic triglyceride [] polyester-8 [] glyceryl stearate [] peg-100 stearate [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] sea whip extract [] isopropyl ppg-2-isodeceth-7 carboxylate [] padina pavonica (thallus) extract [] micrococcus lysate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] astrocaryum murumuru seed butter [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] algae extract [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] adenosine phosphate [] laurdimonium hydroxypropyl hydrolyzed soy protein [] chamomilla recutita (matricaria) [] decarboxy carnosine hcl [] ethylhexyl stearate [] caprylyl glycol [] isohexadecane [] polyethylene [] zeolite [] lecithin [] behenyl alcohol [] xanthan gum [] potassium sulfate [] polysorbate 80 [] steareth-21 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] ammonium acryloyldimethyltaurate/vp copolymer [] sucrose [] tromethamine [] carbomer [] glycerin [] ethylhexyl palmitate [] arginine ferulate [] propylene glycol dicaprate [] hexylene glycol [] disodium edta [] phenoxyethanol
  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    principal display panel:


    CLINIQUE

    SUPERDEFENSE

    AGE DEFENSE MOISTURIZER

    FOR VERY DRY TO DRY SKIN



    1.7 OZ/ 50 ML


    clinique laboratories distr

    new york, ny 10022

    FOLDING CARTON


  • INGREDIENTS AND APPEARANCE
    SUPER DEFENSE  SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN
    oxybenzone, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-708
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-708-011 in 1 CARTON
    1NDC:49527-708-0250 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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