FACE GUARD ADVANCED- octinoxate, octocrylene, titanium dioxide cream 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 Advanced SPF 30

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

Inside BottlePackaging Outside

FACE GUARD ADVANCED 
octinoxate, octocrylene, titanium dioxide cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-283
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.248 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.8 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-283-021 in 1 BOX06/01/2016
1NDC:24653-283-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2016
Labeler - Janssen Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmetics GmbH499187946manufacture(24653-283)

Revised: 6/2016
Document Id: 40ce0875-390e-5a23-e054-00144ff88e88
Set id: 35a7ca9f-a584-10cc-e054-00144ff88e88
Version: 4
Effective Time: 20160619
 
Janssen Cosmetics GmbH