KIEHLS SINCE 1851 BUTTERSTICK LIP TREATMENT BROAD SPECTRUM SPF 25 SUNSCREEN (AVOBENZONE, OCTINOXATE AND OCTOCRYLENE) LIPSTICK [L'OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 BUTTERSTICK LIP TREATMENT BROAD SPECTRUM SPF 25 SUNSCREEN (AVOBENZONE, OCTINOXATE AND OCTOCRYLENE) LIPSTICK [L'OREAL USA PRODUCTS INC]
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NDC 49967-643-01, 49967-643-02
Set ID ef0c7c0d-7b83-400e-aa06-9586ddc57160
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Octinoxate 6%

    Octocrylene 6%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • 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

    cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, beeswax, euphorbia cerifera (candelilla) wax, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, hydrogenated coco-glycerides, copernicia cerifera (carnauba) wax, garcinia indica seed butter, squalane, limnanthes alba (meadowfoam) seed oil, hydrogenated vegetable oil, citrus limon (lemon) peel oil, prunus amygdalus dulcis (sweet almond) oil, limonene, tocopherol, ximenia americana seed oil, citrus medica limonum (lemon) peel extract, stevia rebaudiana extract, alumina, PEG-8, lauroyl lysine, glycine soja (soybean) oil, citral, ascorbyl palmitate, citric acid, ascorbic acid, may contain: titanium dioxide, mica, iron oxides, red 27 lake, red 30 lake, red 7 lake, red 33 lake, barium sulfate, yellow 5 lake

  • Questions or comments?

    Call toll free 1-800-946-4453

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 BUTTERSTICK LIP TREATMENT BROAD SPECTRUM SPF 25 SUNSCREEN 
    avobenzone, octinoxate and octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-643
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    SQUALANE (UNII: GW89575KF9)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    LEMON OIL (UNII: I9GRO824LL)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XIMENIA AMERICANA SEED (UNII: 9WJ8WS9R1L)  
    LEMON PEEL (UNII: 72O054U628)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CITRAL (UNII: T7EU0O9VPP)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-643-011 in 1 CARTON11/01/2016
    14 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-643-022 in 1 CARTON11/01/2016
    24 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2016
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(49967-643)

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