LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE CHAMPAGNE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - FUCSIA SPLENDIDE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE DAMOUR- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE FORMIDABLE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - NATURAL PERSISTANT- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - MIEL ECHANTER- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROUGE PRODIGEUX- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - MARRON ILLIMITE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - CHOCOLAT MAJESTIC- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - CAFE SUCCES- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROUGE GRANDOISE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROUGE RUBI- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - SAUMON ESSENTIEL- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - BOURGOGNE VIF- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - VIOLET POURPRE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - CORAIL MAXIMUM- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ORANGE DELIRANT- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROUGE INTENSE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE FEMME- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - DORE CHOCOLAT- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - MER DE ROSES- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE TENTATION- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE DELICAT- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - FUCSIA DESIR- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROUGE PROVOCATION- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - AMPLIFFIER AMANDIER- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - SOBRIETE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - FIANCEE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROMANCE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - CARMINE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - NOBLESSE- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - MALBEC- octinoxate and oxybenzone lipstick 
LBEL COULEUR LUXE AMPLIFIER XP  AMPLIFYING SPF 15 - ROSE FUCSIA- 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 AMPLIFIER XP
amplifying lipstick SPF 15

Drug Facts

Active Ingredients

Octinoxate 4.7 %, Oxybenzone 0.9%

Purpose

Sunscreen

Uses

Warnings

  • Do not use on damage 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, METHYL HYDROGENATED ROSINATE, POLYETHYLENE, MICA, CASTOR ISOSTEARATE BEESWAX SUCCINATE, HYDROGENATED POLYCYCLOPENTADIENE, SILICA, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), OZOKERITE, ETHYLHEXYL PALMITATE, ISODODECANE, HYDROGENATED POLYISOBUTENE, PARAFFIN, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, DIPALMITOYL HYDROXYPROLINE, CERAMIDE 3, BUTYROSPERMUM PARKII  BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), BETA-SITOSTEROL, DIMETHICONE, PROPYLPARABEN, LUFFA CYLINDRICA SEED OIL, SILICA SILYLATE, METHYLPARABEN, DISTEARDIMONIUM HECTORITE, PARFUM (FRAGRANCE), PEG-40 HYDROGENATED CASTOR OIL, POLYSORBATE 80, PPG-26-BUTETH-26, BHT, TRIMETHYLSILOXYSILICATE, HEDERA HELIX LEAF/STEM EXTRACT (HEDERA HELIX (IVY) LEAF/STEM EXTRACT), RETINYL PALMITATE, TOCOPHERYL ACETATE, BIOFLAVONOIDS, ALLANTOIN, ASCORBYL PALMITATE. MAY CONTAIN: CI 77019 (MICA), CI 77163 (BISMUTH OXYCHLORIDE), CI 15850 (RED 7 LAKE), CI 77742 (MANGANESE VIOLET), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 19140 (YELLOW 5 LAKE), CI 45380 (RED 21 LAKE), CI 15850 (RED 6 LAKE), CI 45410 (RED 27 LAKE), CI 77499 (IRON OXIDES), CALCIUM SODIUM BOROSILICATE, CI 77492 (IRON OXIDES), TALC, CI 42090 (BLUE 1 LAKE), CI 75470 (CARMINE), C9-15 FLUOROALCOHOL PHOSPHATE, LAUROYL LYSINE.

Distributed by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CHAMPAGNE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CHAMPAGNE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA SPLENDIDE

COULEUR LUXE AMPLIFIER XP
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE D'AMOUR

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SPF 15

4 g e (.14 oz.)
L'BEL

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FORMIDABLE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FORMIDABLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATUREL PERSISTANT

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATUREL PERSISTANT

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MIEL ECHANTER

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MIEL ECHANTER

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PRODIGEUX

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PRODIGEUX

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRON ILLIMITÉ

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRON ILLIMITÉ

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CHOCOLAT MAJESTIC

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CHOCOLAT MAJESTIC

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CAFÉ SUCCÈS

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CAFÉ SUCCÈS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE GRANDOISE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE GRANDOISE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE RUBI

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE RUBI

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SAUMON ESSENTIEL

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SAUMON ESSENTIEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - BOURGOGNE VIF

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - BOURGOGNE VIF

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIOLET POURPRE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIOLET POURPRE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAIL MAXIMUM

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAIL MAXIMUM

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ORANGE DÉLIRANT

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ORANGE DÉLIRANT

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FEMME

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FEMME

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - DORÉ CHOCOLAT

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - DORÉ CHOCOLAT

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MER DE ROSES

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MER DE ROSES

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE TENTATION

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE TENTATION

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE DÉLICAT

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE DÉLICAT

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA DÉSIR

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA DÉSIR

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PROVOCATION

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PROVOCATION

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - AMPLIFFIER AMANDIER

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - AMPLIFFIER AMANDIER

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SOBRIETE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SOBRIETE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FIANCEE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FIANCEE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROMANCE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROMANCE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CARMINE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CARMINE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NOBLESSE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NOBLESSE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MALBEC

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MALBEC

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSÉ FUCSIA

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSÉ FUCSIA
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE CHAMPAGNE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-527
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Pink pearl) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-527-021 in 1 BOX
1NDC:13537-527-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - FUCSIA SPLENDIDE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-528
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Fuchsia) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-528-021 in 1 BOX
1NDC:13537-528-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE DAMOUR
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-529
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Natural pink) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-529-021 in 1 BOX
1NDC:13537-529-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE FORMIDABLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-530
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Intense pink pearl) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-530-021 in 1 BOX
1NDC:13537-530-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - NATURAL PERSISTANT
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-531
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Light coffee) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-531-021 in 1 BOX
1NDC:13537-531-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - MIEL ECHANTER
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-532
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Pearl orange coffee) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-532-021 in 1 BOX
1NDC:13537-532-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROUGE PRODIGEUX
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-533
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-533-021 in 1 BOX
1NDC:13537-533-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - MARRON ILLIMITE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-534
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Maroon) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-534-021 in 1 BOX
1NDC:13537-534-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - CHOCOLAT MAJESTIC
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-535
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Dark brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-535-021 in 1 BOX
1NDC:13537-535-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - CAFE SUCCES
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-536
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Coffee) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-536-021 in 1 BOX
1NDC:13537-536-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROUGE GRANDOISE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-537
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Intense red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-537-021 in 1 BOX
1NDC:13537-537-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROUGE RUBI
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-538
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Intense red pearl) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-538-021 in 1 BOX
1NDC:13537-538-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - SAUMON ESSENTIEL
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-539
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Pearl Salmon red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-539-021 in 1 BOX
1NDC:13537-539-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - BOURGOGNE VIF
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-540
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Pearl burgundy) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-540-021 in 1 BOX
1NDC:13537-540-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - VIOLET POURPRE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-541
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPURPLE (Pearl dark purple) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-541-021 in 1 BOX
1NDC:13537-541-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - CORAIL MAXIMUM
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-542
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorORANGE (Light orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-542-021 in 1 BOX
1NDC:13537-542-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ORANGE DELIRANT
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-543
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorORANGE (Intense orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-543-021 in 1 BOX
1NDC:13537-543-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROUGE INTENSE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-544
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Intense yellowish red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-544-021 in 1 BOX
1NDC:13537-544-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE FEMME
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-545
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Pearl bluish pink) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-545-021 in 1 BOX
1NDC:13537-545-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - DORE CHOCOLAT
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-546
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Pearl copper brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-546-021 in 1 BOX
1NDC:13537-546-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - MER DE ROSES
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-547
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorYELLOW (Pearl coral gold) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-547-021 in 1 BOX
1NDC:13537-547-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE TENTATION
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-548
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Pearl reddish pink) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-548-021 in 1 BOX
1NDC:13537-548-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE DELICAT
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-549
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Dark rosewood) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-549-021 in 1 BOX
1NDC:13537-549-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - FUCSIA DESIR
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-550
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Pearl Fuchsia) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-550-021 in 1 BOX
1NDC:13537-550-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROUGE PROVOCATION
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-551
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Dark red matte) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-551-021 in 1 BOX
1NDC:13537-551-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - AMPLIFFIER AMANDIER
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-552
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Dark reddish brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-552-021 in 1 BOX
1NDC:13537-552-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - SOBRIETE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-553
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Light reddish brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-553-021 in 1 BOX
1NDC:13537-553-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - FIANCEE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-554
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Intense pink) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-554-021 in 1 BOX
1NDC:13537-554-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROMANCE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-555
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Dark brown pink) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-555-021 in 1 BOX
1NDC:13537-555-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - CARMINE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-556
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Dark orange red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-556-021 in 1 BOX
1NDC:13537-556-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - NOBLESSE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-557
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorRED (Pearl red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-557-021 in 1 BOX
1NDC:13537-557-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - MALBEC
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-558
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorBROWN (Intense reddish coffee) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-558-021 in 1 BOX
1NDC:13537-558-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
LBEL COULEUR LUXE AMPLIFIER XP   AMPLIFYING SPF 15 - ROSE FUCSIA
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-559
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARMINIC ACID (UNII: CID8Z8N95N)  
LAUROYL LYSINE (UNII: 113171Q70B)  
Product Characteristics
ColorPINK (Light pearl magenta) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-559-021 in 1 BOX
1NDC:13537-559-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2013
Labeler - Ventura Corporation LTD. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-527, 13537-528, 13537-529, 13537-530, 13537-531, 13537-532, 13537-533, 13537-534, 13537-535, 13537-536, 13537-537, 13537-538, 13537-539, 13537-540, 13537-541, 13537-542, 13537-543, 13537-544, 13537-545, 13537-546, 13537-547, 13537-548, 13537-549, 13537-550, 13537-551, 13537-552, 13537-553, 13537-554, 13537-555, 13537-556, 13537-557, 13537-558, 13537-559)

Revised: 6/2013
Document Id: bda95f66-6663-44ca-9320-bc31d6e01a7d
Set id: 50ed6c76-cb88-4250-b24b-2f528274294d
Version: 1
Effective Time: 20130606
 
Ventura Corporation LTD.