Label: FACE GUARD 15- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 August 31, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-816
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24653-816-021 in 1 BOX
    1NDC:24653-816-0150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/02/2012
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Cosmetics Gmbh499187946manufacture(24653-816)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!