ULTRASENSITIVE TINT SPF 30 (TITANIUM DIOXIDE) LOTION [DERMALOGICA, INC.]

ULTRASENSITIVE TINT SPF 30 (TITANIUM DIOXIDE) LOTION [DERMALOGICA, INC.]
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NDC 68479-120-00, 68479-120-02
Set ID 2defa4fa-ca65-4cd1-9ec8-0039360429f7
Category HUMAN OTC DRUG LABEL
Packager Dermalogica, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Titanium Dioxide 11.0%

  • 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 damaged or broken skin.

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

    Stop use and ask a Doctor if rash occurs.

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

    Do not use if seal is broken.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • at least every two hours
      • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats and sunglasses
    • Children under 6 months: ask a doctor
  • Inactive ingredients

    Water/Aqua, Butylene Glycol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Neopentyl Glycol Diethylhexanoate, Arachidyl Alcohol, PEG-10 Dimethicone, Dimethicone, Behenyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Stearyl Dimethicone, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Avena Sativa (Oat) Kernel Extract, Boerhavia Diffusa Root Extract, Melissa Officinalis Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Zingiber Officinale (Ginger) Root Extract, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Thymus Vulgaris (Thyme) Oil, Pelargonium Graveolens Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Oil, Bisabolol, Tocopherol, Lecithin, Panthenol, Sodium Lactate, Sodium PCA, Sorbitol, Proline, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Glycerin, Magnesium Ascorbyl Phosphate, Silica, Arachidyl Glucoside, Cetearyl Alcohol, Ceteareth-20, Sodium DNA, Ascorbyl Tetraisopalmitate, Neopentyl Glycol Diisostearate, Alumina, Methicone, Stearic Acid, Aluminum Hydroxide, Polyglyceryl-2 Dipolyhydroxy Stearate, Polyglyceryl-3 Diiostearate, Xanthan Gum, Magnesium Aluminum Silicate, Carbomer, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Iron Oxides (77491, 77492, 77499).

  • Other information

    • Protect this product from excessive heat and direct sun
  • Questions or comments

    Call toll free
    1-800-831-5150 in the US

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    dermalogica®

    ultra
    sensitive
    tint

    spf
    30

    broad
    spectrum

    NPN# 80031341

    UltraCalming

    1.7 US Fl. Oz.
    50 mL e

    Principal Display Panel - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ULTRASENSITIVE TINT   SPF 30
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Docosanol (UNII: 9G1OE216XY)  
    Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
    Stearyl Dimethicone (400 MPA.S at 50C) (UNII: R327X197HY)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Oat (UNII: Z6J799EAJK)  
    Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
    Melissa Officinalis (UNII: YF70189L0N)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Lemon Peel (UNII: 72O054U628)  
    Centella Asiatica (UNII: 7M867G6T1U)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Ginger (UNII: C5529G5JPQ)  
    Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Thyme Oil (UNII: 2UK410MY6B)  
    Geranium Oil, Algerian Type (UNII: 5Q1I94P4WG)  
    Rosewood Oil (UNII: F2522O5L7B)  
    Orange Oil (UNII: AKN3KSD11B)  
    Levomenol (UNII: 24WE03BX2T)  
    Tocopherol (UNII: R0ZB2556P8)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Panthenol (UNII: WV9CM0O67Z)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sorbitol (UNII: 506T60A25R)  
    Proline (UNII: 9DLQ4CIU6V)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
    Glycerin (UNII: PDC6A3C0OX)  
    Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
    Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Methicone (20 CST) (UNII: 6777U11MKT)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-120-021 in 1 CARTON
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-120-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/14/2012
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(68479-120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-120)

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