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FACE GUARD 15 (Janssen Cosmetics GmbH)

Available Formats

Dosage Form Package Information Links
CREAM 1 BOTTLE, PUMP in 1 BOX (24653-816-02) > 50 mL in 1 BOTTLE, PUMP (24653-816-01) Label Information

Complete FACE GUARD 15 Information

  • Active Ingredients

    Active Ingredients: Titanium Dioxide 4.2% Purpose: Sunscreen


  • 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


  • Ask Doctor Section

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


  • 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


  • 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


  • Front Panel of Box

    2816 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
    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)