KIEHLS SINCE 1851 FACIAL FUEL ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 FACIAL FUEL ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-583-01, 49967-583-02, 49967-583-03, 49967-583-04
Set ID 26f12077-7b61-4fa2-b754-924a47d796a7
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%
    Octisalate 5%
    Octocrylene 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 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, alcohol denat., silica, cyclohexsiloxane, propylene glycol, synthetic fluorphlogopite, cetyl alcohol, dimethicone, stearic acid, palmitic acid, phenoxyethanol, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, fragrance, dimethiconol, zea mays (corn) germ oil, caffeine, tocopherol, disodium EDTA, menthol, limonene, biosacchaide gum-1, sodium hydroxide, ascorbyl glucoside, castanea sativa (chestnut) seed extract, citrus medica limonum (lemon) juice, hydrolyzed soy protein, citrus aurantium dulcis (orange) juice, linalool, citral, red 4, blue 1

  • Questions or comments?

    Call toll free 1-800-946-4453

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 FACIAL FUEL ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 15 SUNSCREEN 
    avobenzone, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 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
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CORN OIL (UNII: 8470G57WFM)  
    CAFFEINE (UNII: 3G6A5W338E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    SPANISH CHESTNUT (UNII: 2MT5XMR2YW)  
    LEMON JUICE (UNII: AGN709ANTJ)  
    ORANGE JUICE (UNII: 5A9KE2L9L3)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRAL (UNII: T7EU0O9VPP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-583-01200 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2013
    2NDC:49967-583-02125 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2013
    3NDC:49967-583-0375 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2013
    4NDC:49967-583-043 mL in 1 PACKET; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2013
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products Inc185931458manufacture(49967-583)

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