Label: KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPER FLUID DAILY UV DEFENSE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN ANTIPOLLUTION LIGHTWEIGHT FORMULA- avobenzone, homosalate, octisalate, and octocrylene lotion

  • NDC Code(s): 49967-812-01, 49967-812-02, 49967-812-03
  • Packager: L'Oreal USA Products Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 30, 2023

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  • Active ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • 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

    Flammble until dry. Do not use near fire, flame or heat.

  • 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

    • shake well before 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. - 2p.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, dimethicone, alcohol denat., silica, styrene/acrylates copolymer, butyloctyl salicylate, PEG-30 dipolyhydroxystearate, polymethylsilsesquioxane, tocopherol, phenoxyethanol, PEG-8 laurate, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, isostearyl alcohol, poly c10-30 alkyl acrylate, p-anisic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, trisodium ethylenediamine disuccinate, sodium dodecylbenzenesulfonate

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPER FLUID DAILY UV DEFENSE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN ANTIPOLLUTION LIGHTWEIGHT FORMULA 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALCOHOL (UNII: 3K9958V90M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-812-011 in 1 CARTON10/01/2022
    1125 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-812-021 in 1 CARTON10/01/2022
    250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49967-812-03125 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2022
    Labeler - L'Oreal USA Products Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(49967-812) , pack(49967-812)
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