Label: SUPER CC PLUS CREAM SPF 30- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 28, 2021

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  • INGREDIENTS AND APPEARANCE
    SUPER CC PLUS CREAM  SPF 30
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-173
    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 CATION - UNII:13S1S8SF37) ZINC CATION2.94 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEPRENONE (UNII: S8S8451A4O)  
    HYDROXYCAPRIC ACID (UNII: B41993WR8W)  
    HYDROXYCAPRYLIC ACID (UNII: 0R6X0G0S8A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LAURETH-12 (UNII: OAH19558U1)  
    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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31645-173-021 in 1 CARTON01/01/2014
    1NDC:31645-173-0135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2014
    Labeler - Physicians Formula Inc (021261805)