KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN (HOMOSALATE, OCTISALATE, OCTOCRYLENE AND TITANIUM DIOXIDE) CREAM [L'OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN (HOMOSALATE, OCTISALATE, OCTOCRYLENE AND TITANIUM DIOXIDE) CREAM [L'OREAL USA PRODUCTS INC]
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NDC 49967-445-01, 49967-445-02
Set ID 7ad06ec1-9c11-4b97-8a44-d4866fd5b523
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Titanium dioxide 4.5%

  • 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 of 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, dicaprylyl ether, glycerin, alcohol denat., polyglyceryl-4 isostearate, ascorbyl glucoside, silica, nylon-12, disteardimonium hectorite, tirbehenin, PEG-30 dipolyhydroxystearate, sodium chloride, phenoxyethanol, disodium stearoyl glutamate, adenosine, aluminum hydroxide; may contain: titanium dioxide, iron oxides

  • Questions or comments?

    Call toll free 1-800-946-4453

  • PRINCIPAL DISPLAY PANEL

    image of a labelimage of a label

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN 
    homosalate, octisalate, octocrylene and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-445
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    NYLON-12 (UNII: 446U8J075B)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ADENOSINE (UNII: K72T3FS567)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-445-011 in 1 CARTON03/01/2013
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-445-023 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2013
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(49967-445)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-445)

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