Label: FACE GUARD 15- titanium dioxide cream

  • NDC Code(s): 24653-816-01, 24653-816-02
  • 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 08/12

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  • Active Ingredients

    Active Ingredients: Titanium Dioxide 4.2% Purpose: Sunscreen

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  • Inactive Ingredients

    Aqua [water], C12-15 alkyl benzoate, dicaprylyl carbonate, butylenes glycol, methylene BIS-benzotriazolyl tetramethylbutylphenol, BIS-ethylhexyloxyphenol methoxyphenyl triazine, cetearyl alcohol, steareth-21, dimethicone, ectoin, trimethylsiloxysilicate, tetra [trimethylsiloxy] silane, glyceryl stearate, ascorbyl palmitate, tocopherol, propylene glycol, xanthan gum, polyhydroxystearic acid, aluminum stearate, alumina, decyl glucoside, lecithin, disodium EDTA, citric acid, ethylhexylglycerin, phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, isobutylparaben

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  • Ask Doctor Section

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

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  • Warnings

    For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

    Keep out of reach of children

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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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  • Front Panel of Box
  • INGREDIENTS AND APPEARANCE
    FACE GUARD 15 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24653-816
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BISOCTRIZOLE (UNII: 8NT850T0YS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ECTOINE (UNII: 7GXZ3858RY)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    GLYCERETH-17 STEARATE (UNII: 02R46S8KUH)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PROPYLENE (UNII: AUG1H506LY)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24653-816-02 1 in 1 BOX
    1 NDC:24653-816-01 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 10/02/2012
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    Name Address ID/FEI Business Operations
    Janssen Cosmetics Gmbh 499187946 manufacture(24653-816)
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