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 Type HUMAN OTC DRUG Item Code (Source) NDC:24653-830
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE .5 g  in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
GLUCAMETACIN (UNII: N1EXE5EHAN)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
STEARETH-21 (UNII: 53J3F32P58)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BISOCTRIZOLE (UNII: 8NT850T0YS)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
ECTOINE (UNII: 7GXZ3858RY)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24653-830-02 1 in 1 BOX
1 NDC:24653-830-01 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 06/01/2012
Labeler - Janssen Cosmetics GmbH (499187946)
Registrant - Janssen Cosmetics GmbH (499187946)
Establishment
Name Address ID/FEI Business Operations
Janssen Cosmetics GmbH 499187946 manufacture(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