KIEHLS SINCE 1851 BROAD SPECTRUM SPF 30 SUNSCREEN POWERFUL WRINKLE REDUCING (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 BROAD SPECTRUM SPF 30 SUNSCREEN POWERFUL WRINKLE REDUCING (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]
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NDC 49967-501-01, 49967-501-02, 49967-501-03
Set ID 3f58b258-b954-41f0-93ad-f6c9fe25718d
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Homosalate 2.7%

    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

  • 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, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, ceteareth-20, phenoxyethanol, butylene glycol, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, p-anisic acid, calcium PCA, adenosine, copper PCA, alteromonas ferment extract, corallina officinalis extract, citric acid, sodium hydroxide

  • Questions or comments?

    Call toll free 1-800-946-4453

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 BROAD SPECTRUM SPF 30 SUNSCREEN POWERFUL WRINKLE REDUCING 
    avobenzone, homosalate, octisalate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-501
    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) HOMOSALATE27 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)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    p-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    ADENOSINE (UNII: K72T3FS567)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-501-0150 mL in 1 JAR; Type 0: Not a Combination Product12/01/2012
    2NDC:49967-501-0275 mL in 1 JAR; Type 0: Not a Combination Product12/01/2012
    3NDC:49967-501-033 mL in 1 PACKET; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2012
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-501) , pack(49967-501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc.177711082pack(49967-501)

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