Label: EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM  SPF 15- avobenzone, homosalate and octisalate cream 

  • NDC Code(s): 49527-013-01
  • Packager: CLINIQUE LABORATORIES INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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%
    Homosalate 3.0%
    Octisalate 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\aqua\eau • tricaprylyl citrate • butylene glycol • butyrospermum parkii (shea butter) • yeast extract\faex\extrait de levure • cetearyl alcohol • polymethyl methacrylate • glycerin • sucrose • polyester-8 • saccharomyces cerevisiae extract • peg-100 stearate • dimethicone • glyceryl stearate • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • saccharomyces lysate extract • scutellaria baicalensis root extract • morus bombycis (mulberry) root extract • betula alba (birch) bark extract • oryza sativa (rice) bran extract • chamomilla recutita (matricaria) extract • helianthus annuus (sunflower) seedcake • caffeine • polyglutamic acid • salicylic acid • propylene glycol dicaprate • sodium rna • dipotassium glycyrrhizate • acetyl glucosamine • phospholipids • arginine • sodium hyaluronate • squalane • cetearyl glucoside • ethylhexylglycerin • isohexadecane • tocopheryl acetate • polysorbate 80 • caprylyl glycol • magnesium ascorbyl phosphate • acrylamide/sodium acryloyldimethyltaurate copolymer • xanthan gum • disodium edta • phenoxyethanol [iln38633]

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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. N.Y., N.Y. 10022

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  • PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

    CLINIQUE

    even better

    dark spot correcting
    hand cream
    broad spectrum
    SPF 15

    ALL SKIN TYPES

    2.5 FL.OZ.LIQ./75 ml e

    PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM   SPF 15
    avobenzone, homosalate, and octisalate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49527-013
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 g  in 1 mL
    HOMOSALATE (HOMOSALATE) HOMOSALATE 0.03 g  in 1 mL
    OCTISALATE (OCTISALATE) OCTISALATE 0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    tricaprylyl citrate  
    butylene glycol  
    shea butter  
    yeast  
    cetostearyl alcohol  
    glycerin  
    sucrose  
    saccharomyces cerevisiae  
    peg-100 stearate  
    dimethicone  
    glyceryl monostearate  
    barley  
    cucumber  
    saccharomyces lysate  
    scutellaria baicalensis root  
    morus australis root  
    betula pubescens bark  
    rice bran  
    matricaria recutita  
    helianthus annuus seedcake  
    caffeine  
    salicylic acid  
    propylene glycol dicaprate  
    glycyrrhizinate dipotassium  
    n-acetylglucosamine  
    arginine  
    hyaluronate sodium  
    squalane  
    cetearyl glucoside  
    ethylhexylglycerin  
    isohexadecane  
    .alpha.-tocopherol acetate  
    polysorbate 80  
    caprylyl glycol  
    magnesium ascorbyl phosphate  
    xanthan gum  
    edetate disodium  
    phenoxyethanol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49527-013-01 1 in 1 CARTON
    1 75 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 09/01/2011
    Labeler - CLINIQUE LABORATORIES INC (173047747)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(49527-013), REPACK(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-013), RELABEL(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(49527-013), RELABEL(49527-013), REPACK(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(49527-013)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(49527-013), RELABEL(49527-013)
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