FACE GUARD 30 SPF- octinoxate and 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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Face Guard SPF 30

Ethylhexyl Methoxycinnamate - 7%

TITANIUM DIOXIDE - 1%

Inactive Ingredients

Aqua [water], C12-15 alkyl benzoate, butylenes glycol, dicaprylyl carbonate, DI-C12-13 alkyl malate, methyl glucose sesquistearate, BIS-ethylhexyloxyphenol methoxyphenyl triazine, steareth-21, diethylamino hydroxybenzoyl hexyl benzoate, cetearyl alcohol, methylene,BIS-benzotriazolyl tetramethylbutylphenol, glyceryl stearate,ethylhexyl triazone, ectoin, aluminum hydroxide, dimethicone, glyceryl caprylate, trimethylsiloxysilicate, xanthan gum, decyl glucoside, lecithin, hydrogen dimethicone, BHT, ascorbyl palmitate, tocopherol, tetrasodium glutamate diacetate, propylene glycol, citric acid, sodium hydroxide, phenoxyethanol, methylparaben

Ask a Doctor

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

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

Keep out of reach of children

Front Panel of Box

2830 Box

FACE GUARD 30 SPF 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24653-830
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.5 g  in 50 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE.5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
C12-15 ALKYL BENZOATE 
BUTYLENE GLYCOL 
DICAPRYLYL CARBONATE 
DI-C12-15 ALKYL FUMARATE 
GLUCAMETACIN 
BEMOTRIZINOL 
STEARETH-21 
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 
CETOSTEARYL ALCOHOL 
BISOCTRIZOLE 
GLYCERYL MONOSTEARATE 
ETHYLHEXYL TRIAZONE 
ECTOINE 
ALUMINUM HYDROXIDE 
DIMETHICONE 
GLYCERYL CAPRYLATE 
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) 
XANTHAN GUM 
DECYL GLUCOSIDE 
LECITHIN, SOYBEAN 
BUTYLATED HYDROXYTOLUENE 
ASCORBYL PALMITATE 
TOCOPHEROL 
TETRASODIUM GLUTAMATE DIACETATE 
PROPYLENE GLYCOL 
CITRIC ACID ACETATE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
METHYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-830-021 in 1 BOX
1NDC:24653-830-0150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2012
Labeler - Janssen Cosmetics GmbH (499187946)
Registrant - Janssen Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmetics GmbH499187946manufacture(24653-830)

Revised: 10/2012
Document Id: 844d4da2-b598-4b01-9703-4cb614ceff28
Set id: 30f4d1d0-6c0f-4e07-b425-a060f9d74224
Version: 1
Effective Time: 20121009
 
Janssen Cosmetics GmbH