FACE GUARD 30 SPF- octinoxate and titanium dioxide cream

Face Guard 30 SPF by

Drug Labeling and Warnings

Face Guard 30 SPF by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

WARNINGS

Keep out of reach of children

Front Panel of Box

INGREDIENTS AND APPEARANCE

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

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)