LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (MARRON ILLIMITE) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (CHOCOLAT MAJESTIC) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (CORAIL MAXIMUM) - ORANGE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (FUCSIA SPLENDIDE) - MAGENTA- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROUGE PRODIGEUX) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROUGE GRANDOISE) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROSE CHAMPAGNE) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROSE DAMOUR) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROUGE RUBI) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (SAUMON ESSENTIEL) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (BOURGOGNE VIF) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (VIOLET POURPRE) - PURPLE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ORANGE DELIRANT) - ORANGE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROSE FEMME) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROUGE INTENSE) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (DORE CHOCOLAT) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (FUCSIA DESIR) - MAGENTA- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (MER DE ROSES) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROUGE PROVOCATION) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROSE TENTATION) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROSE DELICAT) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (CARMINE) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (NOBLESSE) - RED- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (MALBEC) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (AMANDIER) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (SOBRIETE) - BROWN- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (FIANCEE) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROMANCE) - PINK- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (ROSE FUCSIA) - MAGENTA- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15  (MIEL ECHANTER) - ORANGE- octinoxate and oxybenzone lipstick 
Ventura Corporation LTD

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.

----------

L'BEL Couleur Luxe Rouge Amplifier XP amplifyig lipstick SPF 15

Drug Facts

Active Ingredients Purpose
Octinoxate 4.7%,Sunscreen
Oxybenzone 0.9 %Sunscreen

Uses

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

Other information

Inactive ingredients

Isostearyl neopentanoate, diisopropyl dimer dilinoleate, mica, methyl hydrogenated rosinate, polyethylene, castor isostearate beeswax succinate, hydrogenated polycyclopentadiene, ozokerite, silica, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ethylhexyl palmitate, isododecane, hydrogenated polyisobutene, paraffin, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, ceramide 3, butyrospermum parkii (shea) butter, beta-sitosterol, propylparaben, dimethicone, 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.

May contain: mica, bismuth oxychloride, red 7 lake, manganese violet, iron oxides, titanium dioxide, yellow 5 lake, red 21 lake, red 27 lake, red 6 lake, calcium sodium borosilicate, iron oxides, talc, blue 1 lake, carmine, c9-15 fluoroalcohol phosphate, lauroyl lysine.

PUERTO RICO: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON ILLIMITÉ) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (MARRON ILLIMITÉ) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHOCOLAT MAJESTIC) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (CHOCOLAT MAJESTIC) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAIL MAXIMUM) - ORANGE

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (CORAIL MAXIMUM) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SPLENDIDE) - MAGENTA

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (FUCSIA SPLENDIDE) - MAGENTA

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PRODIGEUX) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROUGE PRODIGEUX) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE GRANDOISE) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROUGE GRANDOISE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE CHAMPAGNE) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROSE CHAMPAGNE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE D'AMOUR) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROSE D'AMOUR) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE RUBI) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROUGE RUBI) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SAUMON ESSENTIEL) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (SAUMON ESSENTIEL) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BOURGOGNE VIF) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (BOURGOGNE VIF) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIOLET POURPRE) - PURPLE

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (VIOLET POURPRE) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ORANGE DÉLIRANT) - ORANGE

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ORANGE DÉLIRANT) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE FEMME) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROSE FEMME) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE INTENSE) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROUGE INTENSE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (DORÉ CHOCOLAT) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (DORÉ CHOCOLAT) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DÉSIR) - MAGENTA

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (FUCSIA DÉSIR) - MAGENTA

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MER DE ROSES) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (MER DE ROSES) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PROVOCATION) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROUGE PROVOCATION) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE TENTATION) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROSE TENTATION) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE DÉLICAT) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROSE DÉLICAT) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CARMINE) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (CARMINE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NOBLESSE) - RED

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (NOBLESSE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALBEC) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (MALBEC) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (AMANDIER) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (AMANDIER) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOBRIETE) - BROWN

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (SOBRIETE) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FIANCEE) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (FIANCEE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROMANCE) - PINK

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROMANCE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE FUCSIA) - MAGENTA

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (ROSE FUCSIA) - MAGENTA

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MIEL ECHANTER) - ORANGE

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

Principal Display Panel - 4 g Tube Box - (MIEL ECHANTER) - ORANGE
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MARRON ILLIMITE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-410
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-410-021 in 1 BOX
1NDC:13537-410-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CHOCOLAT MAJESTIC) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-411
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-411-041 in 1 BOX
1NDC:13537-411-034 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CORAIL MAXIMUM) - ORANGE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-412
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-412-061 in 1 BOX
1NDC:13537-412-054 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FUCSIA SPLENDIDE) - MAGENTA
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-413
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-413-081 in 1 BOX
1NDC:13537-413-074 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE PRODIGEUX) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-414
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-414-101 in 1 BOX
1NDC:13537-414-094 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE GRANDOISE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-415
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-415-121 in 1 BOX
1NDC:13537-415-114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE CHAMPAGNE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-416
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-416-141 in 1 BOX
1NDC:13537-416-134 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE DAMOUR) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-417
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-417-161 in 1 BOX
1NDC:13537-417-154 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE RUBI) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-418
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-418-181 in 1 BOX
1NDC:13537-418-174 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (SAUMON ESSENTIEL) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-419
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-419-201 in 1 BOX
1NDC:13537-419-194 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (BOURGOGNE VIF) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-420
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-420-221 in 1 BOX
1NDC:13537-420-214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (VIOLET POURPRE) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-115
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-115-241 in 1 BOX
1NDC:13537-115-234 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ORANGE DELIRANT) - ORANGE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-116
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-116-261 in 1 BOX
1NDC:13537-116-254 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE FEMME) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-117
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-117-281 in 1 BOX
1NDC:13537-117-274 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE INTENSE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-118
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-118-301 in 1 BOX
1NDC:13537-118-294 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (DORE CHOCOLAT) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-119
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-119-321 in 1 BOX
1NDC:13537-119-314 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FUCSIA DESIR) - MAGENTA
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-146
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-146-341 in 1 BOX
1NDC:13537-146-334 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MER DE ROSES) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-149
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-149-361 in 1 BOX
1NDC:13537-149-354 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE PROVOCATION) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-151
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-151-381 in 1 BOX
1NDC:13537-151-374 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE TENTATION) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-158
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-158-401 in 1 BOX
1NDC:13537-158-394 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE DELICAT) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-159
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-159-421 in 1 BOX
1NDC:13537-159-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CARMINE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-160
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-160-421 in 1 BOX
1NDC:13537-160-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (NOBLESSE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-161
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-161-421 in 1 BOX
1NDC:13537-161-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MALBEC) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-162
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-162-421 in 1 BOX
1NDC:13537-162-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (AMANDIER) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-163
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-163-421 in 1 BOX
1NDC:13537-163-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (SOBRIETE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-164
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-164-421 in 1 BOX
1NDC:13537-164-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FIANCEE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-165
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-165-421 in 1 BOX
1NDC:13537-165-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROMANCE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-166
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-166-421 in 1 BOX
1NDC:13537-166-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE FUCSIA) - MAGENTA
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-167
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-167-421 in 1 BOX
1NDC:13537-167-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MIEL ECHANTER) - ORANGE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-168
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)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
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)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 (UNII: 481744AI4O)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-168-421 in 1 BOX
1NDC:13537-168-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-410, 13537-411, 13537-412, 13537-413, 13537-414, 13537-415, 13537-416, 13537-417, 13537-418, 13537-419, 13537-420, 13537-115, 13537-116, 13537-117, 13537-118, 13537-119, 13537-146, 13537-149, 13537-151, 13537-158, 13537-159, 13537-160, 13537-161, 13537-162, 13537-163, 13537-164, 13537-165, 13537-166, 13537-167, 13537-168)

Revised: 1/2014
Document Id: b23d5fa1-de9b-408a-aa56-3af65d835f45
Set id: 1e56c9b8-d249-48a0-a700-fdb0244c48e8
Version: 1
Effective Time: 20140130
 
Ventura Corporation LTD