FACE GUARD 30 SPF (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [JANSSEN COSMETICS GMBH]

FACE GUARD 30 SPF (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [JANSSEN COSMETICS GMBH]
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NDC 24653-830-01, 24653-830-02
Set ID 30f4d1d0-6c0f-4e07-b425-a060f9d74224
Category HUMAN OTC DRUG LABEL
Packager Janssen Cosmetics GmbH
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate - 7%

    TITANIUM DIOXIDE - 1%

  • Inactive Ingredients

    Aqua [water], C12-15 alkyl benzoate, butylenes glycol, dicaprylyl carbonate, DI-C12-13 alkyl malate, methyl glucose sesquistearate, BIS-ethylhexyloxyphenol methoxyphenyl triazine, steareth-21, diethylamino hydroxybenzoyl hexyl benzoate, cetearyl alcohol, methylene,BIS-benzotriazolyl tetramethylbutylphenol, glyceryl stearate,ethylhexyl triazone, ectoin, aluminum hydroxide, dimethicone, glyceryl caprylate, trimethylsiloxysilicate, xanthan gum, decyl glucoside, lecithin, hydrogen dimethicone, BHT, ascorbyl palmitate, tocopherol, tetrasodium glutamate diacetate, propylene glycol, citric acid, sodium hydroxide, phenoxyethanol, methylparaben

  • Ask a Doctor

    Discontinue use if signs of irritation or rash appear. If irritation or rash persists consult a doctor

  • Directions

    Simply apply onto the face, neck and neckline after cleansing in the morning and then apply the usual day cream on top

    Children under six months of age: consult a doctor

  • WARNINGS

    Keep out of reach of children

  • Front Panel of Box

    2830 Box

  • INGREDIENTS AND APPEARANCE
    FACE GUARD 30 SPF 
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-830
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
    GLUCAMETACIN (UNII: N1EXE5EHAN)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BISOCTRIZOLE (UNII: 8NT850T0YS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24653-830-021 in 1 BOX
    1NDC:24653-830-0150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2012
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Cosmetics GmbH499187946manufacture(24653-830)

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