Label: FACE GUARD 30 SPF- octinoxate and titanium dioxide cream

  • NDC Code(s): 24653-830-01, 24653-830-02
  • Packager: Janssen Cosmetics GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate - 7%

    TITANIUM DIOXIDE - 1%

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  • 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

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  • Ask a Doctor

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

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  • 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

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  • WARNINGS

    Keep out of reach of children

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  • Front Panel of Box
  • INGREDIENTS AND APPEARANCE
    FACE GUARD 30 SPF 
    octinoxate and titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24653-830
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 3.5 g  in 50 mL
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE .5 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    C12-15 ALKYL BENZOATE  
    BUTYLENE GLYCOL  
    DICAPRYLYL CARBONATE  
    DI-C12-15 ALKYL FUMARATE  
    GLUCAMETACIN  
    BEMOTRIZINOL  
    STEARETH-21  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE  
    CETOSTEARYL ALCOHOL  
    BISOCTRIZOLE  
    GLYCERYL MONOSTEARATE  
    ETHYLHEXYL TRIAZONE  
    ECTOINE  
    ALUMINUM HYDROXIDE  
    DIMETHICONE  
    GLYCERYL CAPRYLATE  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)  
    XANTHAN GUM  
    DECYL GLUCOSIDE  
    LECITHIN, SOYBEAN  
    BUTYLATED HYDROXYTOLUENE  
    ASCORBYL PALMITATE  
    TOCOPHEROL  
    TETRASODIUM GLUTAMATE DIACETATE  
    PROPYLENE GLYCOL  
    CITRIC ACID ACETATE  
    SODIUM HYDROXIDE  
    PHENOXYETHANOL  
    METHYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24653-830-02 1 in 1 BOX
    1 NDC:24653-830-01 50 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/01/2012
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    Name Address ID/FEI Business Operations
    Janssen Cosmetics GmbH 499187946 manufacture(24653-830)
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