FACE GUARD ADVANCED (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE CREAM) CREAM [JANSSEN COSMETICS GMBH]

FACE GUARD ADVANCED (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE CREAM) CREAM [JANSSEN COSMETICS GMBH]
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NDC 24653-283-01, 24653-283-02
Set ID 35a7ca9f-a584-10cc-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Janssen Cosmetics GmbH
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

  • INGREDIENTS AND APPEARANCE
    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)

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