Label: EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15- avobenzone, homosalate, and 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 November 11, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 3.0%
    Homosalate 3.0%
    Octisalate 5.0%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • 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.

  • 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
  • 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]

  • Other information

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

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM   SPF 15
    avobenzone, homosalate, and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.03 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRICAPRYLYL CITRATE (UNII: BXW1GAI4TA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BARLEY (UNII: 5PWM7YLI7R)  
    CUCUMBER (UNII: YY7C30VXJT)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    MORUS INDICA ROOT (UNII: 1VL55O45RF)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    RICE BRAN (UNII: R60QEP13IC)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    ARGININE (UNII: 94ZLA3W45F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-013-011 in 1 CARTON09/01/201107/14/2021
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2011
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062RELABEL(49527-013) , REPACK(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157REPACK(49527-013) , RELABEL(49527-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC PALC102631997REPACK(49527-013) , RELABEL(49527-013)
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