Label: LBEL COULER LUXE SUPREME XP- octinoxate, oxybenzone, and titanium dioxide lipstick
LBEL COULER LUXE SUPREME XP- octinoxate, oxybenzone, and titanium dioxide 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 November 8, 2010

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  • Active Ingredients

    Octinoxate 0.98%, Oxybenzone 0.47%, Titanium Dioxide 0.94%.

  • Purpose

    Sunscreen.

  • Uses

    Helps prevent sunburn.

  • Warnings

    Stop use and ask doctor if rash or irritation develops and lasts.

  • Directions

    Apply smoothly before sun exposure and as needed. Minimal sun protection product.

  • Inactive ingredients

    ricinus communis seed oil (ricinus communis (castor) seed oil), diisostearyl malate, caprylic/capric triglyceride, decyl oleate, ozokerite, cera alba (beeswax), copernicia cerifera cera (copernicia cerifera (carnauba) wax), candelilla cera (euphorbia cerifera (candelilla) wax), isopropyl lanolate, sorbitan sesquioleate, CI 77019 (mica), hydrogenated polyisobutene, vp/hexadecene copolymer, isostearyl neopentanoate, octyldodecanol, parfum (fragrance), propylparaben, lecithin, bht, dimethicone, arachidyl propionate, tocopheryl acetate, retinyl palmitate, trimethylsiloxysilicate, ethyl linoleate, ethyl linolenate. may contain: CI 77891 (titanium dioxide), CI 77163 (bismuth oxychloride), CI 19140 (yellow 5 lake), CI 15850 (red 6 lake), CI 45410 (red 27 lake), CI 15850 (red 7 lake), CI 77491, CI 77492, CI 77499 (iron oxides), CI 45380 (red 21 lake), oleyl alcohol, talc, C9-13 fluoroalcohol, phosphoric acid, CI 75470 (carmine).

  • PRINCIPAL DISPLAY PANEL - 11.1 g Kit

    COFFRET COULEUR

    makeup palette for the face, eyes and lips

    11,1 g e (.38 oz.)

    This palette contains:

    • L'Bel Couleur Luxe Supreme XP / lipstick with long duration and shine SPF 8
    • L'Bel Coffret Couleur / eyeshadow quartet
    • L'Bel Couleur luxe Blush Delicat xp / compact blusher
    • L'Bel Gloss Coffret Couleur / lip gloss

    L'BEL

    Principal Display Panel - 11.1 g Kit
  • PRINCIPAL DISPLAY PANEL - 11.1 g Kit

    COFFRET COULEUR

    makeup palette for the face, eyes and lips

    11,1 g e (.38 oz.)

    This palette contains:

    • L'Bel Couleur Luxe Supreme XP / lipstick with long duration and shine SPF 8
    • L'Bel Coffret Couleur / eyeshadow quartet
    • L'Bel Couleur luxe Blush Delicat xp / compact blusher
    • L'Bel Gloss Coffret Couleur / lip gloss

    L'BEL

    Principal Display Panel - 11.1 g Kit
  • INGREDIENTS AND APPEARANCE
    LBEL COULER LUXE SUPREME XP   ROSACE, EXCENTRIQUE, HARMONIE
    octinoxate, oxybenzone, and titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-660
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0098 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0047 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0094 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICA (UNII: V8A1AW0880)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TALC (UNII: 7SEV7J4R1U)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-660-123 in 1 KIT
    1NDC:14783-660-110.7 g in 1 TRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/26/2010
    LBEL COULER LUXE SUPREME XP   SUBLIME, ORANGE, SOBRIETE
    octinoxate, oxybenzone, and titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-661
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0098 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0047 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0094 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICA (UNII: V8A1AW0880)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TALC (UNII: 7SEV7J4R1U)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-661-123 in 1 KIT
    1NDC:14783-661-110.7 g in 1 TRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/26/2010
    Labeler - Ventura International, Limited (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    BelStar, S.A.880160197MANUFACTURE
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