KIEHLS SINCE 1851 ULTRA FACIAL BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [L’OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 ULTRA FACIAL BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [L’OREAL USA PRODUCTS INC]
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NDC 49967-099-01, 49967-099-02, 49967-099-03
Set ID fb9daea3-c249-417c-ad34-3e89f3118559
Category HUMAN OTC DRUG LABEL
Packager L’Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Avobenzone 3%

    Homosalate 5%

    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

  • 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, glycerin, squalene, dimethicone, PEG-100 stearate, glyceryl stearate, silica, octyldodecanol, stearic acid, phenoxyethanol, palmitic acid, tocopherol, dicaprylyl carbonate, steareth-100, acrylates/c10-30 alkyl acrylate crosspolymer, ophiopogon japonicus root extract, carbomer, chlorphenesin, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, sodium hydroxide, citrus aurantium dulcis (orange) peel oil, limonene, ectoin, hydrolyzed hyaluronic acid, myristic acid, mentha piperita (peppermint) oil, pseudoalteromonas ferment extract, ethylhexylglycerin, linalool, salicylic acid

  • 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 labelimage of a label

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 ULTRA FACIAL BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-099
    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) HOMOSALATE50 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)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-099-0150 mL in 1 JAR; Type 0: Not a Combination Product11/01/2015
    2NDC:49967-099-02125 mL in 1 JAR; Type 0: Not a Combination Product11/01/2015
    3NDC:49967-099-033 mL in 1 PACKET; Type 0: Not a Combination Product11/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2015
    Labeler - L’Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L’Oreal USA, Inc.185931458manufacture(49967-099)

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