Label: TOTAL EYE CARE SPF 15- titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 23, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Titanium Dioxide (4.5%)

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use on broken or damaged skin.

    When using this product keep out of eyes. Rinse with water to remove.

    If irritation develops, discontinue use.

    Do not use on infants under 6 months old.

    Stop use and ask a physician if too much skin irritation or sensitivity develops or increases.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • After cleansing in the morning, gently pat around the entire eye area, blending inward from the outer corner.
  • Inactive ingredients

    Water (Aqua), C12-15 Alkyl Ethylhexanoate, Butylene Glycol, Glycerin, Silica, Lactic Acid, Cetearyl Alcohol, Potassium Cetyl Phosphate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Spiraea Ulmaria Flower Extract, Centella Asiatica Extract, Taurine, Leucine, Valine, Tyrosine, Arginine, Lysine, Sodium PCA, Tocopheryl Acetate, Bisabolol, Lauric Acid, Aluminum Hydroxide, Allantoin, Ceteareth-20, Xanthan Gum, Sodium Hydroxide, Propylene Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Talc, Iron Oxides (CI 77492, CI 77491), Mica (CI 77019).

  • Questions?

    1-800-831-5150 in USA

  • PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

    total
    eye
    care

    spf
    15
    broad
    spectrum

    NPN #80011194
    0.5 US Fl. Oz.
    15 mL e

    dermalogica®

    Principal Display Panel - 15 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOTAL EYE CARE   SPF 15
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Citrus Aurantium Flower (UNII: O730ZX2Z83)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Filipendula Ulmaria Flower (UNII: 06L18L32G6)  
    Centella Asiatica (UNII: 7M867G6T1U)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Lysine (UNII: K3Z4F929H6)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Levomenol (UNII: 24WE03BX2T)  
    Arginine (UNII: 94ZLA3W45F)  
    Lauric Acid (UNII: 1160N9NU9U)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Taurine (UNII: 1EQV5MLY3D)  
    Tyrosine (UNII: 42HK56048U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Allantoin (UNII: 344S277G0Z)  
    Leucine (UNII: GMW67QNF9C)  
    Valine (UNII: HG18B9YRS7)  
    Talc (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BARIUM CARBONATE (UNII: 6P669D8HQ8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-360-021 in 1 CARTON
    115 mL in 1 TUBE
    2NDC:68479-360-014 mL in 1 TUBE
    3NDC:68479-360-002 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/29/2012
    Labeler - Dermalogica (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab177711082MANUFACTURE(68479-360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-360)
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