Label: CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25- avobenzone, octisalate, octocrylene, and oxybenzone cream

  • NDC Code(s): 49527-709-01
  • Packager: CLINIQUE LABORATORIES INC
  • 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 March 5, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Avobenzone 3.0%
    Octisalate 5.0%
    Octocrylene 1.3%
    Oxybenzone 5.0%

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  • Purpose

    Sunscreen

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  • Use

    helps prevent sunburn

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  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
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  • Inactive ingredients

    water • dimethicone • butylene glycol • butyloctyl salicylate • isononyl isononanoate • polyester-8 • silica • glycerin • polysilicone-11 • triticum vulgare (wheat bran) extract • algae extract • laminaria saccharina extract • olea europaea (olive) fruit extract • coffea robusta seed extract • echinacea pallida (coneflower) extract • rosmarinus officinalis (rosemary) extract • sea whip extract • astrocaryum murumuru seed butter • adenosine phosphate • trehalose • disodium nadh • padina pavonica (thallus) extract • creatine • sodium rna • caffeine • micrococcus lysate • nordihydroguaiaretic acid • sodium dna • phytosphingosine • linoleic acid • cholesterol • ascorbyl tocopheryl maleate • sodium hyaluronate • aminopropyl ascorbyl phosphate • tocopheryl acetate • trisiloxane • sucrose • laurdimonium hydroxypropyl hydrolyzed soy protein • lecithin • hexylene glycol • ethylhexyl stearate • ethylhexyl palmitate • decarboxy carnosine hcl • propylene glycol dicaprate • chamomilla recutita (matricaria) • zeolite • caprylyl glycol • polyethylene • xanthan gum • laureth-4 • laureth-23 • polysorbate 20 • ammonium acryloyldimethyltaurate/vp copolymer • acrylic acid/vp crosspolymer • arginine ferulate • tromethamine • disodium edta • phenoxyethanol [iln37043]

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  • Other information

    protect the product in this container from excessive heat and direct sun

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  • SPL UNCLASSIFIED SECTION

    © CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

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  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    CLINIQUE

    superdefense

    age defense moisturizer
    broad spectrum SPF 25

    COMBINATION OILY TO OILY

    POIDS NET WT. 1.7 OZ./50 ml e

    Principal Display Panel - 50 ml Jar Carton
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  • INGREDIENTS AND APPEARANCE
    CLINIQUE   SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25
    avobenzone, octisalate, octocrylene, and oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-709
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.3 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    saccharina latissima thallus (UNII: 68CMP2MB55)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
    ECHINACEA PALLIDA (UNII: 904CK3270L)  
    ROSEMARY (UNII: IJ67X351P9)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PADINA PAVONICA (UNII: 177U06NHZI)  
    CREATINE (UNII: MU72812GK0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    SUCROSE (UNII: C151H8M554)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-23 (UNII: N72LMW566G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49527-709-01 1 in 1 CARTON
    1 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 04/01/2004
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC Kabushiki Kaisha 712808195 RELABEL(49527-709) , REPACK(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    ARAMIS, INC 042918826 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-709) , RELABEL(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 787336577 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 949264774 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 618107429 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-709)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(49527-709)
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