FACE GUARD ADVANCED- octinoxate, octocrylene, titanium dioxide cream cream

Face Guard Advanced by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient Section

Active Ingredients: Ethylhexyl methoxycinnamate 7,494%, octocrylene 6%, titanium dioxide (nano) 0,99%

Other Ingredients Section

Cosmetic Ingredients: Aqua [water], propylheptyl caprylate, butylenes glycol, methyl glucose sesquistearate, diethylamino hydroxybenzoyl hexyl benzoate, hydrogenated polyisobutene, glycerin, steareth-21, methylene BIS-benzotriazolyl tetramethylbutylphenol, BIS-ethylhexyloxyphenol methoxyphenyl triazine, cetearyl alcohol, pentylene glycol, sodium potassium aluminum silicate, silica, glyceryl stearate, phenyl trimethicone, xanthan gum, ectoin, thermus thermophillus ferment, aluminum hydroxide, glyceryl caprylate, decyl glucoside, lecithin, hydrogen dimethicone, ascorbyl palmitate, tocopherol, BHT, tetrasodium glutamate diacetate, propylene glycol, citric acid, sodium hydroxide, parfum [fragrance], phenoxyethanol, potassium sorbate,

CI 77 891 [titanium dioxide]

Purpose Section

UV protection serum, SPF 30, against premature light induced skin aging. With photostable UVA/ UVB filters, Ectoin
and biotechnological agents against IR-rays. Ideal for all skin types and for combining with all day care products.

Direction For Use

Directions: Simply apply onto the face, neck and neckline after cleansing in the morning and then apply the usual day cream on
top.

Warnings

Children under six months of age: consult a doctor.

Warning: For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with
water. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor.

Keep out of reach of children.

Principal Label - Box and Bottle

Packaging outside

INGREDIENTS AND APPEARANCE

FACE GUARD ADVANCED 
octinoxate, octocrylene, titanium dioxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.3 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.248 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
GLYCERIN (UNII: PDC6A3C0OX)
BEMOTRIZINOL (UNII: PWZ1720CBH)
BISOCTRIZOLE (UNII: 8NT850T0YS)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
STEARETH-21 (UNII: 53J3F32P58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ECTOINE (UNII: 7GXZ3858RY)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL MONOLAURATE (UNII: 2Z947R568V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-283-02	1 in 1 BOX	06/01/2016
1	NDC: 24653-283-01	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2016

Labeler - Janssen Cosmetics GmbH (499187946)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cosmetics GmbH		499187946	manufacture(24653-283)