Label: ORGANIC WEAR 100% NATURAL ORIGIN TINTED MOISTURIZER SPF 15- titanium dioxide cream

  • NDC Code(s): 31645-145-01, 31645-145-02
  • Packager: Physicians Formula Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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Drug Label Information

Updated December 28, 2018

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  • INGREDIENTS AND APPEARANCE
    ORGANIC WEAR 100% NATURAL ORIGIN TINTED MOISTURIZER  SPF 15
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-145
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.95 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    TALC (UNII: 7SEV7J4R1U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:31645-145-02 1 in 1 BOX 02/01/2009
    1 NDC:31645-145-01 44 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/01/2009
    Labeler - Physicians Formula Inc (021261805)
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