Label: CONTINUOUS COVERAGE MAKEUP SPF 15- titanium dioxide 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 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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