Label: CONTINUOUS COVERAGE MAKEUP SPF 15- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 19, 2011

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  • DRUG FACTS

    ACTIVE INGREDIENT: 2% TITANIUM DIOXIDE

  • PURPOSE

    PURPOSE: SUNSCREEN

    USE: HELPS PREVENT SUNBURN
  • WARNINGS

    WARNINGS:

    FOR EXTERNAL USE ONLY


  • DO NOT USE

    DO NOT USE ON DAMAGED OR BROKEN SKIN

  • WHEN USING

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF RASH OCCURS

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INDICATIONS & USAGE

    DIRECTIONS

    • FOR SUNSCREEN USE:
    • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
    • REAPPLY AT LEAST EVERY 2 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 AM TO 2 PM
      • WEAR LING-SLEEVED SHIRTS, PANTS AND SUNGLASSES
      • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: water\aqua\eau [] polydecene [] talc [] butylene glycol [] isostearic acid [] glyceryl stearate [] peg-100 stearate [] phenyl trimethicone [] magnesium aluminum silicate [] tromethamine [] cholesterol [] algin [] microcrystalline cellulose [] cellulose gum [] disteardimonium hectorite [] sodium hyaluronate [] triethyl citrate [] lecithin [] stearic acid [] aluminum hydroxide [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)

  • QUESTIONS

    PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL



    CLINIQUE

    CONTINUOUS

    COVERAGE

    MAKEUP

    BROAD SPECTRUM

    SPF 15

    NET WT. 1 OZ/ 30 ML


    CLINIQUE LABORATORIES DIST
    NY NY 10022
    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    CONTINUOUS COVERAGE MAKEUP  SPF 15
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    IRON (UNII: E1UOL152H7)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-010-011 in 1 CARTON
    1NDC:49527-010-0230 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/1992
    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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