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LBEL (Ventura Corporation Ltd.)

Available Formats

Dosage Form Package Information Links
LIPSTICK 12 TUBE in 1 CARTON (13537-019-02) > 4 g in 1 TUBE (13537-019-01) Label Information
LIPSTICK 12 TRAY in 1 CARTON (13537-019-04) > 11.4 g in 1 TRAY (13537-019-03) Label Information

Complete LBEL Information

  • Active Ingredients

    Octinoxate 7.1 % , Oxybenzone 1.6%


  • Purpose

    sunscreen


  • Uses

    Helps prevent sunburn


  • Warnings

    Stop use if skin rash occurs


  • Inactive ingredients

    ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, polymethyl methacrylate, (butyrospermum parkii (shea butter), ozokerite, copernicia cerifera (carnauba) wax, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, octyldodecanol, disteardimonium hectorite, caprylic/capric triglyceride, phenoxyethanol, tocopheryl acetate, aloe barbadensis leaf extract, fragrance, microcrystalline wax, propylene carbonate, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, propylparaben, isobutylparaben, glycosphingolipids. May contain: mica, titanium dioxide, red 7 lake, iron oxides, yellow 5 lake, red 30 lake, red 21 lake, bismuth oxychloride, talc, red 40 lake, blue 1 lake, carmine, hydrogenated polyisobutene, palmitic acid.


  • SPL UNCLASSIFIED SECTION

    USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.


  • PRINCIPAL DISPLAY PANEL - 4 g Carton

    COULEUR LUXE ROUGE IRRÉSISTIBLE

    maximum hydration lipstick SPF 17

    4 g e (.14 oz.)

    L'BEL

    Principal Display Panel - 4 g Carton

  • INGREDIENTS AND APPEARANCE
    LBEL   COULEUR LUXE ROUGE IRRESISTIBLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-019
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.016 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13537-019-02 12 in 1 CARTON
    1 NDC:13537-019-01 4 g in 1 TUBE
    2 NDC:13537-019-04 12 in 1 CARTON
    2 NDC:13537-019-03 11.4 g in 1 TRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 08/10/2011
    Labeler - Ventura Corporation Ltd. (602751344)
    Establishment
    Name Address ID/FEI Business Operations
    BelStar, S.A. 880160197 MANUFACTURE