KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS CLEARLY CORRECTIVE DARK CIRCLE PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN (TITANIUM DIOXIDE) LOTION [L’OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS CLEARLY CORRECTIVE DARK CIRCLE PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN (TITANIUM DIOXIDE) LOTION [L’OREAL USA PRODUCTS INC]
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NDC 49967-561-01, 49967-561-02
Set ID 18a6e253-9c13-4d9c-9429-8e0b95d95445
Category HUMAN OTC DRUG LABEL
Packager L’Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Titanium dioxide 7.85%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases 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.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 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 decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses

    • children under 6 months of age: Ask a doctor
  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, cyclopentasiloxane, isododecane, dimethicone, glycerin, nylon-12, PEG-9 polydimethylsiloxyethyl dimethicone, butylene glycol, cyclohexasiloxane, silica, dimethicone crosspolymer, disteardimonium hectorite, 3-o-ethyl ascorbic acid, zinc PCA, PEG-10 dimethicone, cetyl PEG/PPG-10/1 dimethicone, phenoxyethanol, sodium chloride, polyglyceryl-4 isostearate, caprylyl glycol, ethylhexylglycerin, chlorphenesin, disodium stearoyl glutamate, caffeine, PEG-9, glycyrrhiza glabra extract/licorice root extract, aluminum hydroxide; may contain: titanium dioxide, iron oxides, mica

  • Questions or comments?

    Call toll free 1-800-946-4453

    Monday - Friday (9 a.m. to 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS CLEARLY CORRECTIVE DARK CIRCLE PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-561
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE78.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    CAFFEINE (UNII: 3G6A5W338E)  
    POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-561-011 in 1 CARTON01/01/2015
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-561-021.5 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2015
    Labeler - L’Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L’Oreal USA, Inc.185931458manufacture(49967-561)

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