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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24653-816
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
DICAPRYLYL CARBONATE 
BUTYLENE GLYCOL 
BISOCTRIZOLE 
CETOSTEARYL ALCOHOL 
BEMOTRIZINOL 
STEARETH-21 
DIMETHICONE 
ECTOINE 
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) 
GLYCERETH-17 STEARATE 
ALUMINUM STEARATE 
ALUMINUM OXIDE 
XANTHAN GUM 
ASCORBYL PALMITATE 
TOCOPHEROL 
DECYL GLUCOSIDE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
ETHYLHEXYLGLYCERIN 
HYDROGENATED SOYBEAN LECITHIN 
EDETIC ACID 
PROPYLENE 
CITRIC ACID ACETATE 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
ISOBUTYLPARABEN 
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)

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