Label: LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE NATURAL) - BROWN- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROJO VIF) - BROWN- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (MOKA) - PINK- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (MANDARINE) - PURPLE- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (CAPUCCINO) - PURPLE- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (VIN) - PURPLE- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (FUCHSIA INTENSE) - PURPLE- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROUGE BRILLANCE) - BROWN- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROUGE INTENSE) - PURPLE- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (FUCHSIA BRILLANCE) - RED- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE BRILLANCE) - RED- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE CLASSIQUE) - RED- octinoxate and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    14783-441-01, 14783-441-02, 14783-442-03, 14783-442-04, view more
    14783-443-05, 14783-443-06, 14783-444-07, 14783-444-08, 14783-445-09, 14783-445-10, 14783-447-13, 14783-447-14, 14783-450-19, 14783-450-20, 14783-451-21, 14783-451-22, 14783-452-23, 14783-452-24, 14783-453-11, 14783-453-12, 14783-454-15, 14783-454-16, 14783-455-17, 14783-455-18
  • Packager: Ventura International LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 3, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate (7.1%)Sunscreen
    Oxybenzone (1.6%)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 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

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect this product in this container form excesive heat and direct sun.
  • Inactive ingredients

    Ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, ozokerite, butyrospermum parkii (shea butter), tridecyl stearate, copernicia cerifera cera (carnauba) wax, polymethyl methacrylate, neopentyl glycol dicaprylate/dicaprate, disteardimonium hectorite, octyldodecanol, caprylic/capric triglyceride, phenoxyethanol, propylene carbonate, tocopheryl acetate, parfum (fragrance),microcrystalline wax, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, propylparaben, aloe barbadensis leaf extract, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, glycosphingolipids.

    May contain:
    Mica , red 7 lake , iron oxides, titanium dioxide , red 30 lake, yellow 5 lake , red 21 lake , bismuth oxychloride, red 40 lake , talc, blue 1 lake , hydrogenated polyisobutene, carmine, palmitic acid.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE NATURAL) - BROWN

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE NATURAL) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO VIF) - BROWN

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROJO VIF) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MOKA) - PINK

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (MOKA) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MANDARINE) - PURPLE

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (MANDARINE) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CAPUCCINO) - PURPLE

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (CAPUCCINO) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN) - PURPLE

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (VIN) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCHSIA INTENSE) - PURPLE

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (FUCHSIA INTENSE) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE BRILLANCE) - BROWN

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE BRILLANCE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE INTENSE) - PURPLE

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE INTENSE) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCHSIA BRILLANCE) - RED

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (FUCHSIA BRILLANCE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE BRILLANCE) - RED

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE BRILLANCE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE CLASSIQUE) - RED

    COULEUR LUXE ROUGE IRRÉSISTIBLE
    maximum hydration lipstick SPF 17

    Net Weight 0.14 oz. (4 g)
    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE CLASSIQUE) - RED
  • INGREDIENTS AND APPEARANCE
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (ROSE NATURAL) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-441
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-441-021 in 1 BOX
    1NDC:14783-441-014 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (ROJO VIF) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-442-041 in 1 BOX
    1NDC:14783-442-034 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (MOKA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-443
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-443-061 in 1 BOX
    1NDC:14783-443-054 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (MANDARINE) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-444-081 in 1 BOX
    1NDC:14783-444-074 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (CAPUCCINO) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-445
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-445-101 in 1 BOX
    1NDC:14783-445-094 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (VIN) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-453
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-453-121 in 1 BOX
    1NDC:14783-453-114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (FUCHSIA INTENSE) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-447
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-447-141 in 1 BOX
    1NDC:14783-447-134 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (ROUGE BRILLANCE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-454
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-454-161 in 1 BOX
    1NDC:14783-454-154 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (ROUGE INTENSE) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-455
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-455-181 in 1 BOX
    1NDC:14783-455-174 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (FUCHSIA BRILLANCE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-450-201 in 1 BOX
    1NDC:14783-450-194 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (ROSE BRILLANCE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-451-221 in 1 BOX
    1NDC:14783-451-214 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17   (ROSE CLASSIQUE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-452
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
    tridecyl trimellitate (UNII: FY36J270ES)  
    high density polyethylene (UNII: UG00KM4WR7)  
    shea butter (UNII: K49155WL9Y)  
    tridecyl stearate (UNII: A8OE252M6L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    octyldodecanol (UNII: 461N1O614Y)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene carbonate (UNII: 8D08K3S51E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    petrolatum (UNII: 4T6H12BN9U)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cholesterol (UNII: 97C5T2UQ7J)  
    propylparaben (UNII: Z8IX2SC1OH)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    mica (UNII: V8A1AW0880)  
    d&c red no. 7 (UNII: ECW0LZ41X8)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide red (UNII: 1K09F3G675)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    d&c red no. 30 (UNII: 2S42T2808B)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    d&c red no. 21 (UNII: 08744Z6JNY)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    fd&c red no. 40 (UNII: WZB9127XOA)  
    talc (UNII: 7SEV7J4R1U)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-452-241 in 1 BOX
    1NDC:14783-452-234 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2014
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-441, 14783-442, 14783-443, 14783-444, 14783-445, 14783-453, 14783-447, 14783-454, 14783-455, 14783-450, 14783-451, 14783-452)