Label: FOUNDATION PRIMER SPF 15- titanium dioxide , zinc oxide , octinoxate cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 8, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: ZINC OXIDE (19.5% W/W), OCTINOXATE(5% W/W) , TITANIUM DIOXIDE (1.5% W/W)


  • WARNINGS

    Warnings; Contains OXYBENZONE. For external use only. Not to be swallowed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear.




  • INDICATIONS & USAGE

    Directions; In the morning , after applying Essence , apply Day Moisturizer With SPF 15 liberally over face and neck.


  • PRINCIPAL DISPLAY PANEL

    Image of Carton

  • INGREDIENTS AND APPEARANCE
    FOUNDATION PRIMER SPF 15 
    titanium dioxide , zinc oxide , octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-4189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.222 g  in 14 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.73 g  in 14 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.7 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    CERESIN (UNII: Q1LS2UJO3A)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    FRUIT (UNII: C2AIY4ERZC)  
    FERULA ASSA-FOETIDA ROOT (UNII: 3U9288P88T)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-4189-014 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/11/2009
    Labeler - Mary Kay Inc. (103978839)
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