EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROUGE RUBI) - RED- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (SOBRIETE) - BROWN- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROSE TENTATION) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROMANCE) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (CARMINE) - RED- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (MALBEC) - BROWN- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (GENUINE ROUGE) - RED- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (BELLE NUDE) - BEIGE- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (FUCSIA PASSION) - PURPLE- octinoxate lipstick 
EFFET PARFAIT ROUGE AMPLIFIER  AMPLIFYING SPF 15 (VIN CHIC) - BROWN- octinoxate lipstick 
Ventura International 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.

----------

EFFET PARFAIT ROUGE AMPLIFIER
AMPLIFYING LIPSTICK SPF 15

Drug Facts

Active Ingredients

OCTINOXATE 7.270 %

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

DIISOPROPYL DIMER DILINOLEATE, METHYL HYDROGENATED ROSINATE, POLYETHYLENE, MICA, CASTOR ISOSTEARATE BEESWAX SUCCINATE, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED POLYCYCLOPENTADIENE, SILICA, EUPHORBIA CERIFERA (CANDELILLA) WAX, OZOKERITE, ETHYLHEXYL PALMITATE, ISODODECANE, HYDROGENATED POLYISOBUTENE, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, DIPALMITOYL HYDROXYPROLINE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BETA-SITOSTEROL, DIETHYLHEXYL SYRINGYLIDENEMALONATE, DIMETHICONE, SILICA SILYLATE, PHENOXYETHANOL, LUFFA CYLINDRICA SEED OIL, FRAGRANCE, CAPRYLYL GLYCOL, TRIMETHYLSILOXYSILICATE, CHLORPHENESIN, CERAMIDE 3, TOCOPHERYL ACETATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALLANTOIN.

MAY CONTAIN:
MANGANESE VIOLET, BISMUTH OXYCHLORIDE, MICA, TITANIUM DIOXIDE, IRON OXIDES, RED 27 LAKE, CALCIUM ALUMINUM BOROSILICATE, YELLOW 5 LAKE, RED 7 LAKE, SYNTHETIC FLUORPHLOGOPITE, RED 21 LAKE, TALC, BLUE 1 LAKE, CARMINE, PEG-8 METHYL ETHER TRIETHOXYSILANE, TIN OXIDE.

US: Dist by Ventura Int Ltd.
DBA Belcorp USA, San
Francisco, CA 94111.

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DESIR) - BROWN

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DESIR) - BROWN

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SALMON ESSENTIAL) - ORANGE

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SALMON ESSENTIAL) - ORANGE

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

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

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BELLE NUDE) - BEIGE

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BELLE NUDE) - BEIGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA PASSION) - PURPLE

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA PASSION) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN CHIC) - BROWN

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN CHIC) - BROWN
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-870
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-870-021 in 1 BOX
1NDC:14783-870-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROUGE RUBI) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-871
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-871-041 in 1 BOX
1NDC:14783-871-034 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (SOBRIETE) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-872
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-872-061 in 1 BOX
1NDC:14783-872-054 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-873
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-873-081 in 1 BOX
1NDC:14783-873-074 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-874
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-874-101 in 1 BOX
1NDC:14783-874-094 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROSE TENTATION) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-875
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-875-121 in 1 BOX
1NDC:14783-875-114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-876
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-876-141 in 1 BOX
1NDC:14783-876-134 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-877
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-877-161 in 1 BOX
1NDC:14783-877-154 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROMANCE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-878
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-878-181 in 1 BOX
1NDC:14783-878-174 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-879
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-879-201 in 1 BOX
1NDC:14783-879-194 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-881
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-881-221 in 1 BOX
1NDC:14783-881-214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-882
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-882-241 in 1 BOX
1NDC:14783-882-234 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (CARMINE) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-883
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-883-261 in 1 BOX
1NDC:14783-883-254 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (MALBEC) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-884
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-884-281 in 1 BOX
1NDC:14783-884-274 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-885
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-885-301 in 1 BOX
1NDC:14783-885-294 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-887
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-887-321 in 1 BOX
1NDC:14783-887-314 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (GENUINE ROUGE) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-888
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-888-341 in 1 BOX
1NDC:14783-888-334 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-889
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-889-361 in 1 BOX
1NDC:14783-889-354 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-890
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-890-381 in 1 BOX
1NDC:14783-890-374 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (BELLE NUDE) - BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-800-401 in 1 BOX
1NDC:14783-800-394 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (FUCSIA PASSION) - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-801-421 in 1 BOX
1NDC:14783-801-414 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (VIN CHIC) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-802
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.072 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
SHEA BUTTER (UNII: K49155WL9Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALLANTOIN (UNII: 344S277G0Z)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-802-441 in 1 BOX
1NDC:14783-802-434 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/11/2014
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-870, 14783-871, 14783-872, 14783-873, 14783-874, 14783-875, 14783-876, 14783-877, 14783-878, 14783-879, 14783-881, 14783-882, 14783-883, 14783-884, 14783-885, 14783-887, 14783-888, 14783-889, 14783-890, 14783-800, 14783-801, 14783-802)

Revised: 6/2015
Document Id: efc91cf8-4e65-494d-a8dc-39fd1d54ffd9
Set id: 381aa212-713a-4df1-9a0c-1c2d3af86e8d
Version: 2
Effective Time: 20150619
 
Ventura International LTD