FACE GUARD 15- titanium dioxide cream 
Janssen Cosmetics GmbH

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.

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Titanium Dioxide

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

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)

Revised: 8/2012
Document Id: 4b0df926-8098-428f-bea5-8e264cbd5e32
Set id: 5edcbad5-9a0c-4df4-a7a0-c64c7e486b36
Version: 3
Effective Time: 20120831
 
Janssen Cosmetics GmbH