LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (MARRON ILLIMITE) - BROWN- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (CHOCOLAT MAJESTIC) - BROWN- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (CORAIL MAXIMUM) - ORANGE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (ROMANCE) - PINK- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (ROSE FUCSIA) - MAGENTA- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (MIEL ECHANTER) - ORANGE- octinoxate and oxybenzone lipstick

LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 by

Drug Labeling and Warnings

LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 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 INGREDIENT

Active Ingredients	Purpose
Octinoxate 4.7%,	Sunscreen
Oxybenzone 0.9 %	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 damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor.

Other information

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

Inactive ingredients

Isostearyl neopentanoate, diisopropyl dimer dilinoleate, mica, methyl hydrogenated rosinate, polyethylene, castor isostearate beeswax succinate, hydrogenated polycyclopentadiene, ozokerite, silica, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ethylhexyl palmitate, isododecane, hydrogenated polyisobutene, paraffin, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, ceramide 3, butyrospermum parkii (shea) butter, beta-sitosterol, propylparaben, dimethicone, luffa cylindrica seed oil, silica silylate, methylparaben, disteardimonium hectorite, fragrance, peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, bht, trimethylsiloxysilicate, hedera helix (ivy) leaf/stem extract, retinyl palmitate, tocopheryl acetate, bioflavonoids, allantoin, ascorbyl palmitate.

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

SPL UNCLASSIFIED SECTION

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

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

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

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick
SPF 15

Net Weight 0.14 oz. (4 g)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MARRON ILLIMITE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-410-02	1 in 1 BOX
1	NDC: 13537-410-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CHOCOLAT MAJESTIC) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-411
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-411-04	1 in 1 BOX
1	NDC: 13537-411-03	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CORAIL MAXIMUM) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-412-06	1 in 1 BOX
1	NDC: 13537-412-05	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FUCSIA SPLENDIDE) - MAGENTA
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-413-08	1 in 1 BOX
1	NDC: 13537-413-07	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE PRODIGEUX) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-414
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-414-10	1 in 1 BOX
1	NDC: 13537-414-09	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE GRANDOISE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-415-12	1 in 1 BOX
1	NDC: 13537-415-11	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE CHAMPAGNE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-416-14	1 in 1 BOX
1	NDC: 13537-416-13	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE DAMOUR) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-417-16	1 in 1 BOX
1	NDC: 13537-417-15	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE RUBI) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-418
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-418-18	1 in 1 BOX
1	NDC: 13537-418-17	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (SAUMON ESSENTIEL) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-419
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-419-20	1 in 1 BOX
1	NDC: 13537-419-19	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (BOURGOGNE VIF) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-420-22	1 in 1 BOX
1	NDC: 13537-420-21	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (VIOLET POURPRE) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-115-24	1 in 1 BOX
1	NDC: 13537-115-23	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ORANGE DELIRANT) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-116-26	1 in 1 BOX
1	NDC: 13537-116-25	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE FEMME) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-117-28	1 in 1 BOX
1	NDC: 13537-117-27	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE INTENSE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-118-30	1 in 1 BOX
1	NDC: 13537-118-29	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (DORE CHOCOLAT) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-119-32	1 in 1 BOX
1	NDC: 13537-119-31	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FUCSIA DESIR) - MAGENTA
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-146-34	1 in 1 BOX
1	NDC: 13537-146-33	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MER DE ROSES) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-149-36	1 in 1 BOX
1	NDC: 13537-149-35	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE PROVOCATION) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-151-38	1 in 1 BOX
1	NDC: 13537-151-37	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE TENTATION) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-158-40	1 in 1 BOX
1	NDC: 13537-158-39	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE DELICAT) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-159-42	1 in 1 BOX
1	NDC: 13537-159-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CARMINE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-160-42	1 in 1 BOX
1	NDC: 13537-160-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (NOBLESSE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-161-42	1 in 1 BOX
1	NDC: 13537-161-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MALBEC) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-162-42	1 in 1 BOX
1	NDC: 13537-162-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (AMANDIER) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-163-42	1 in 1 BOX
1	NDC: 13537-163-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (SOBRIETE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-164-42	1 in 1 BOX
1	NDC: 13537-164-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FIANCEE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-165-42	1 in 1 BOX
1	NDC: 13537-165-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROMANCE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-166-42	1 in 1 BOX
1	NDC: 13537-166-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE FUCSIA) - MAGENTA
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-167
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-167-42	1 in 1 BOX
1	NDC: 13537-167-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MIEL ECHANTER) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.047 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.009 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
MICA (UNII: V8A1AW0880)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-168-42	1 in 1 BOX
1	NDC: 13537-168-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2014

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-410, 13537-411, 13537-412, 13537-413, 13537-414, 13537-415, 13537-416, 13537-417, 13537-418, 13537-419, 13537-420, 13537-115, 13537-116, 13537-117, 13537-118, 13537-119, 13537-146, 13537-149, 13537-151, 13537-158, 13537-159, 13537-160, 13537-161, 13537-162, 13537-163, 13537-164, 13537-165, 13537-166, 13537-167, 13537-168)