Label: KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN UV SERUM BROAD SPECTRUM SPF 50 PLUS SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

  • NDC Code(s): 49967-053-01, 49967-053-02, 49967-053-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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  • Active ingredients

    Avobenzone 3%

    Homosalate 7%

    Octisalate 5%

    Octocrylene 7%

  • 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, glycerin, c15-19 alkane, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, tocopherol, sodium stearoyl glutamate, butylene glycol, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, carbomer, sodium lactate, sodium hydroxide, polysorbate 20, polyglycerin-3, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN UV SERUM BROAD SPECTRUM SPF 50 PLUS SUNSCREEN 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-053
    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) HOMOSALATE70 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-053-011 in 1 CARTON07/01/2023
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-053-021 in 1 CARTON07/01/2023
    215 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:49967-053-032 mL in 1 PACKET; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2023
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-053) , pack(49967-053)
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