Label: FACEBLOCK- titanium dioxide and zinc oxide lotion

  • 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 March 18, 2011

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  • active ingredients

    Titanium Dioxide (6.7%), Zinc Oxide (9.2%).

  • other ingredients

    Water (Aqua), Cyclopentasiloxane, Dimethicone, Butylene Glycol, Dicaprylyl Ether, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Camellia Sinensis Leaf Extract, Lavandula Hybrida Oil, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, Tocopherol, Dimethicone/PEG-10/15 Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Sodium DNA, Sodium Hyaluronate, Sodium PCA, Dipotassium Glycyrrhizate, Silica, Carbomer, Sodium Chloride, Sodium Citrate, Linalool, Tetrasodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben.

  • warnings

    For external use only, not to be swallowed.

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

    If irritation develops, discontinue use.

    Do not use on infants under 6 months old.

  • PRINCIPAL DISPLAY PANEL - 50 ml Carton

    super
    sensitive
    faceblock

    spf 30

    NPN# 80005547
    AUS L 138151

    1.7 FL OZ / 50 ml e

    dermalogica®

    Principal Display Panel - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    FACEBLOCK   SPF30 SUPER SENSITIVE
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.35 mL  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.6 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Linalool, Dl- (UNII: D81QY6I88E)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-111-501 in 1 BOX
    150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/09/2005
    Labeler - Gordon Laboratories, Inc (008328619)
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