EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]

EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]
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NDC 49527-056-01
Set ID 756cb656-2f79-4e7f-b4b3-18d6e8930921
Category HUMAN OTC DRUG LABEL
Packager CLINIQUE LABORATORIES LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 6.0%
    Titanium Dioxide 3.8%
    Zinc Oxide 3.0%

  • 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 • methyl trimethicone • phenyl trimethicone • triethylhexanoin • dimethicone • butylene glycol • trimethylsiloxysilicate • peg-10 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • aluminum hydroxide • c12-15 alkyl benzoate • glycerin • citrus grandis (grapefruit) peel extract • betula alba (birch) bark extract • saccharomyces lysate extract • camellia sinensis leaf extract • astrocaryum murumuru seed butter • yeast extract\faex\extrait de levure • salicylic acid • sodium hyaluronate • caprylyl glycol • jojoba esters • sodium myristoyl sarcosinate • sodium chloride • tocopheryl acetate • acetyl glucosamine • caprylyl methicone • polyglyceryl-6 polyricinoleate • methicone • dimethicone crosspolymer-3 • lecithin • magnesium ascorbyl phosphate • tetrahexyldecyl ascorbate • disteardimonium hectorite • isopropyl titanium triisostearate • laureth-7 • dipropylene glycol • dimethicone/peg-10/15 crosspolymer • disodium edta • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • bismuth oxychloride (ci 77163) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499) [iln43351]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

    C

    CLINIQUE

    even better glow

    light reflecting makeup
    broad spectrum
    SPF 15

    1 FL.OZ.LIQ./30 ml e

    PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15 
    octinoxate, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0675 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.04275 g  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.03375 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-056-011 in 1 CARTON03/20/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/20/2017
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062RELABEL(49527-056) , REPACK(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC PALC102631997REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774REPACK(49527-056) , RELABEL(49527-056)

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