SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PHYSICIANS FORMULA INC]

SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PHYSICIANS FORMULA INC]
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NDC 31645-164-01, 31645-164-02
Set ID e271a9ff-7453-4241-a965-ac540f530729
Category HUMAN OTC DRUG LABEL
Packager PHYSICIANS FORMULA INC
Generic Name
Product Class
Product Number
Application Number PART352
  • WARNINGS AND PRECAUTIONS

    Warning: For external use only. When using this product, keep out of eyes. rinse with water to remove.

  • ACTIVE INGREDIENT

    Active Ingredients: Titanium Dioxide 5.76% Zinc Oxide 2.94%

  • 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.

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    SUPER BB 10-IN-1 BEAUTY BALM CREAM  SPF 30
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.76 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-12 (UNII: OAH19558U1)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MICA (UNII: V8A1AW0880)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31645-164-021 in 1 BOX
    1NDC:31645-164-0135 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/05/2013
    Labeler - PHYSICIANS FORMULA INC (021261805)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHYSICIANS FORMULA INC825048945manufacture(31645-164)

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