Label: FACE GUARD ADVANCED- octinoxate, octocrylene, titanium dioxide cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24653-283-01, 24653-283-02 - Packager: Janssen Cosmetics GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 19, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Section
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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
- Direction For Use
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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
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INGREDIENTS AND APPEARANCE
FACE GUARD ADVANCED
octinoxate, octocrylene, titanium dioxide cream creamProduct 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)
