Label: LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15- octinoxate and oxybenzone lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 16, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 4.7 %, Oxybenzone 0.9%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    • Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    • For external use only.

    • Do not use on damage 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

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    isostearyl neopentanoate, diisopropyl dimer dilinoleate, methyl hydrogenated rosinate, mica, polyethylene, castor isostearate beeswax succinate, ethylhexyl methoxycinnamate, hydrogenated polycyclopentadiene, silica, copernicia cerifera (carnauba ) wax, euphorbia cerifera (candelilla) wax, ozokerite, ethylhexyl palmitate, isododecane, hydrogenated polyisobutene, paraffin, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, benzophenone-3, ceramide 3, butyrospermum parkii (shea) butter, beta-sitosterol, dimethicone, propylparaben, luffa cylindrica seed oil, silica silylate, methylparaben, disteardimonium hectorite, fragrance, peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, bht, trimethylsiloxysilicate, hedera helix (ivy) leaf/stem extract, retinyl palmitate, tocopheryl acetate, bioflavonoids, allantoin, ascorbyl palmitate.

  • SPL UNCLASSIFIED SECTION

    US: Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

    COULEUR LUXE AMPLIFIER XP
    amplifying lipstick
    SPF 15

    4 g e (.14 oz.)

    L'BEL

    Principal Display Panel - 4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    isostearyl neopentanoate (UNII: 411THY156Q)  
    diisopropyl dilinoleate (UNII: 5323S7S2LR)  
    mica (UNII: V8A1AW0880)  
    high density polyethylene (UNII: UG00KM4WR7)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    carnauba wax (UNII: R12CBM0EIZ)  
    candelilla wax (UNII: WL0328HX19)  
    ethylhexyl palmitate (UNII: 2865993309)  
    isododecane (UNII: A8289P68Y2)  
    paraffin (UNII: I9O0E3H2ZE)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    glyceryl isostearate (UNII: HYE7O27HAO)  
    isostearyl alcohol (UNII: Q613OCQ44Y)  
    dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)  
    ceramide 3 (UNII: 4370DF050B)  
    shea butter (UNII: K49155WL9Y)  
    .beta.-sitosterol (UNII: S347WMO6M4)  
    dimethicone (UNII: 92RU3N3Y1O)  
    propylparaben (UNII: Z8IX2SC1OH)  
    luffa aegyptiaca seed oil (UNII: 1A281RJ859)  
    methylparaben (UNII: A2I8C7HI9T)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    ppg-26-buteth-26 (UNII: 2II1K6TZ4P)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    hedera helix leaf (UNII: ZP9XFG71A7)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    citrus bioflavonoids (UNII: BD70459I50)  
    allantoin (UNII: 344S277G0Z)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-012-021 in 1 BOX
    1NDC:14783-012-014 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/14/2012
    Labeler - Ventura International LTD. (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-012)
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