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
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-100-01, 13537-100-02, 13537-101-03, 13537-101-04, view more13537-102-07, 13537-102-08, 13537-103-09, 13537-103-10, 13537-104-11, 13537-104-12, 13537-105-13, 13537-105-14, 13537-106-15, 13537-106-16, 13537-107-17, 13537-107-18, 13537-108-19, 13537-108-20, 13537-109-21, 13537-109-22, 13537-111-23, 13537-111-24, 13537-443-05, 13537-443-06 - Packager: Ventura Corporation 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
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
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE NATURAL - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO VIF - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MOKA - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MANDARINE - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CAPUCCINO - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIN - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCHSIA INTENSE - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE BRILLANCE - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCHSIA BRILLANCE - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE BRILLANCE - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CLASSIQUE - RED
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INGREDIENTS AND APPEARANCE
LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 Â (ROSE NATURAL) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-100 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-100-02 1 in 1 BOX 1 NDC:13537-100-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (ROJO VIF) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-101 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-101-04 1 in 1 BOX 1 NDC:13537-101-03 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (MOKA) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-443 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-443-06 1 in 1 BOX 1 NDC:13537-443-05 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (MANDARINE) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-102 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-102-08 1 in 1 BOX 1 NDC:13537-102-07 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (CAPUCCINO) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-103 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-103-10 1 in 1 BOX 1 NDC:13537-103-09 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (VIN) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-104 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-104-12 1 in 1 BOX 1 NDC:13537-104-11 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (FUCHSIA INTENSE) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-105 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-105-14 1 in 1 BOX 1 NDC:13537-105-13 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (ROUGE BRILLANCE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-106 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-106-16 1 in 1 BOX 1 NDC:13537-106-15 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (ROUGE INTENSE) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-107 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-107-18 1 in 1 BOX 1 NDC:13537-107-17 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (FUCHSIA BRILLANCE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-108 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-108-20 1 in 1 BOX 1 NDC:13537-108-19 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (ROSE BRILLANCE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-109 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-109-22 1 in 1 BOX 1 NDC:13537-109-21 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17  (ROSE CLASSIQUE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-111 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)  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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-111-24 1 in 1 BOX 1 NDC:13537-111-23 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/31/2014 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-100, 13537-101, 13537-443, 13537-102, 13537-103, 13537-104, 13537-105, 13537-106, 13537-107, 13537-108, 13537-109, 13537-111)