Label: ULTRA SENSITIVE FACEBLOCK SPF 25- titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 August 3, 2011

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  • active ingredient

    Titanium Dioxide (7.8%).

  • warnings

    For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Apply prior to sun exposure.

    Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner.

    Do not use on infants under 6 months old.

  • other ingredients

    Water (Aqua), Octyldodecyl Neopentanoate, Isononyl Isononanoate, Butylene Glycol, Neopentyl Glycol Diethylhexanoate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, Stearic Acid, Neopentyl Glycol Diisostearate, Melissa Officinalis (Balm Mint) Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Echinacea Purpurea (Coneflower) Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Centella Asiatica (Hydrocotyl) Extract, Proline, Lecithin, Magnesium Ascorbyl Phosphate, Panthenol, Retinyl Palmitate, Tocopherol, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Geranium Maculatum Oil, Lavendula Angustifolia (Lavender) Oil, Thymus Vulgaris (Thyme) Oil, Aluminum Hydroxide, Disodium EDTA, Xanthan Gum, Propylparaben, Linalool, Stearyl Dimethicone, Ceteareth-20, Polyglyceryl-6 Polyricinoleate, Sodium PCA, Sodium Lactate, Sorbitol, Magnesium Aluminum Silicate, Diazolidinyl Urea, Methylparaben, Talc, Limonene, Geraniol, Citronellol, Iron Oxides (CI 77491, CI 77492, CI 77499).

  • SPL UNCLASSIFIED SECTION

    Dermalogica, Dist.
    Los Angeles, CA 90009 USA
    1-800-831-5150

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    dermalogica®

    ultra
    sensitive
    faceblock

    spf 25

    NPN# 80012093
    AUST L 78910

    1.7 FL OZ / 50 ml e

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ULTRA SENSITIVE FACEBLOCK SPF 25 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide4000 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Neopentyl Glycol Disostearate (UNII: 4M6OQ34JWW)  
    Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Lemon Peel (UNII: 72O054U628)  
    Centella Asiatica (UNII: 7M867G6T1U)  
    Proline (UNII: 9DLQ4CIU6V)  
    Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
    Panthenol (UNII: WV9CM0O67Z)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Tocopherol (UNII: R0ZB2556P8)  
    Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
    Rosewood Oil (UNII: F2522O5L7B)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Thyme Oil (UNII: 2UK410MY6B)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Sorbitol (UNII: 506T60A25R)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Talc (UNII: 7SEV7J4R1U)  
    Geraniol (UNII: L837108USY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (Light Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-011-501 in 1 BOX
    150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2009
    Labeler - Gordon Laboratories, Inc (008328619)