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 (oc .......T 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

EFFET PARFAIT ROUGE AMPLIFIER by

Drug Labeling and Warnings

EFFET PARFAIT ROUGE AMPLIFIER by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE 7.270 %

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only.

• Do not use on 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

• Apply liberally and evenly 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.

Other information

• Protect the product in this container from excessive heat and direct sun.

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.

SPL UNCLASSIFIED SECTION

P.R.: Dist by
Ventura Corp, Ltd., San
Juan, Puerto Rico 00926.

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 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 - (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 - (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 - (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 - (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 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 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 - (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 - (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 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 - (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 - (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 - (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 - (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 - (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 - (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 - (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 - (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 - (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 - (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 - (VIN CHIC) - BROWN

L'BEL

EFFET
PARFAIT
ROUGE
AMPLIFIER

amplifying
lipstick SPF 15

Net Weight 0.14 oz (4g)

INGREDIENTS AND APPEARANCE

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-870
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-870-02	1 in 1 BOX
1	NDC: 13537-870-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROUGE RUBI) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-871
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-871-04	1 in 1 BOX
1	NDC: 13537-871-03	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (SOBRIETE) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-872
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-872-06	1 in 1 BOX
1	NDC: 13537-872-05	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-873
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-873-08	1 in 1 BOX
1	NDC: 13537-873-07	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-874
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-874-10	1 in 1 BOX
1	NDC: 13537-874-09	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROSE TENTATION) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-875
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-875-12	1 in 1 BOX
1	NDC: 13537-875-11	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-876
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-876-14	1 in 1 BOX
1	NDC: 13537-876-13	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-877
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-877-16	1 in 1 BOX
1	NDC: 13537-877-15	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROMANCE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-878
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-878-18	1 in 1 BOX
1	NDC: 13537-878-17	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-879
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-879-20	1 in 1 BOX
1	NDC: 13537-879-19	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-881
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-881-22	1 in 1 BOX
1	NDC: 13537-881-21	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-882
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-882-24	1 in 1 BOX
1	NDC: 13537-882-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (CARMINE) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-883
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-883-26	1 in 1 BOX
1	NDC: 13537-883-25	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (MALBEC) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-884
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-884-28	1 in 1 BOX
1	NDC: 13537-884-27	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-885
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-885-30	1 in 1 BOX
1	NDC: 13537-885-29	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-887
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-887-32	1 in 1 BOX
1	NDC: 13537-887-31	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (GENUINE ROUGE) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-888-34	1 in 1 BOX
1	NDC: 13537-888-33	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-889
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-889-36	1 in 1 BOX
1	NDC: 13537-889-35	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-890
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-890-38	1 in 1 BOX
1	NDC: 13537-890-37	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (BELLE NUDE) - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-800-40	1 in 1 BOX
1	NDC: 13537-800-39	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (FUCSIA PASSION) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-801-42	1 in 1 BOX
1	NDC: 13537-801-41	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

EFFET PARFAIT ROUGE AMPLIFIER   AMPLIFYING SPF 15 (VIN CHIC) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.072 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-802-44	1 in 1 BOX
1	NDC: 13537-802-43	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/11/2014

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-870, 13537-871, 13537-872, 13537-873, 13537-874, 13537-875, 13537-876, 13537-877, 13537-878, 13537-879, 13537-881, 13537-882, 13537-883, 13537-884, 13537-885, 13537-887, 13537-888, 13537-889, 13537-890, 13537-800, 13537-801, 13537-802)