Label: LAURA MERCIER TINTED MOISTURIZER SPF-20 SAND- octinoxate ,meradimate 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 May 2, 2011

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  • ACTIVE INGREDIENT

    Octinoxate (7.5%) , Meradimate (3.5%)


  • WARNINGS

    WARNINGS : AFOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF RASH OR IRRITATION APPEAR.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Direction for use : Apply   to cleansed skin with fingertips. Layer fro additional coverage.


  • INACTIVE INGREDIENT

    Ingredients : Purified Water , Cetearyl Alcohol (And) PEG-40 Castor Oil (And) POE-20 , Dimethicone ,Polyglyceryl-4 Isostearate ,Cyclomethicone , DEA-Ceryl  Phospate, Hexyl Laurate ,Kalaya Oil , Tocopheryl Acetate ,Cetyl Dimethicone Copolyol , Diazolidinyl Urea, Sodium Dehydroacetate ,Sodium Hyaluronate , Allantoin ,Carbomer Methylparaben, Magensium Aluminum Silicate , Sodium Ascorbate, Propylparaben, (+/-) Titanium Dioxide , Iron Oixde , Mica




  • PRINCIPAL DISPLAY PANEL

     Image of Carton

  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER TINTED MOISTURIZER SPF-20 SAND 
    octinoxate ,meradimate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3 mg  in 40 mg
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE1.4 mg  in 40 mg
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65342-1378-040 mg in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/13/2005
    Labeler - Gurwitch Products, L.L.C. (884875246)
    Registrant - Beautymanuracuting Solutions Corperation (783200723)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beautymanuracuting Solutions Corperation783200723manufacture
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