DailyMed - LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE CHAMPAGNE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - FUCSIA SPLENDIDE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE DAMOUR- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SP .......FYING SPF 15 - CARMINE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - NOBLESSE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - MALBEC- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE FUCSIA- octinoxate and oxybenzone lipstick

Contains inactivated NDC Code(s)
NDC Code(s): 14783-305-01, 14783-305-02, 14783-306-01, 14783-306-02, view more
14783-307-01, 14783-307-02, 14783-308-01, 14783-308-02, 14783-309-01, 14783-309-02, 14783-310-01, 14783-310-02, 14783-311-01, 14783-311-02, 14783-312-01, 14783-312-02, 14783-313-01, 14783-313-02, 14783-314-01, 14783-314-02, 14783-315-01, 14783-315-02, 14783-316-01, 14783-316-02, 14783-317-01, 14783-317-02, 14783-318-01, 14783-318-02, 14783-319-01, 14783-319-02, 14783-320-01, 14783-320-02, 14783-321-01, 14783-321-02, 14783-322-01, 14783-322-02, 14783-323-01, 14783-323-02, 14783-324-01, 14783-324-02, 14783-325-01, 14783-325-02, 14783-326-01, 14783-326-02, 14783-327-01, 14783-327-02, 14783-328-01, 14783-328-02, 14783-329-01, 14783-329-02, 14783-330-01, 14783-330-02, 14783-331-01, 14783-331-02, 14783-332-01, 14783-332-02, 14783-333-01, 14783-333-02, 14783-334-01, 14783-334-02, 14783-335-01, 14783-335-02, 14783-336-01, 14783-336-02, 14783-337-01, 14783-337-02
Packager: Ventura International LTD.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 7, 2013

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Octinoxate 4.7 %, Oxybenzone 0.9%
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

ISOSTEARYL NEOPENTANOATE, DIISOPROPYL DIMER DILINOLEATE, METHYL HYDROGENATED ROSINATE, POLYETHYLENE, MICA, CASTOR ISOSTEARATE BEESWAX SUCCINATE, HYDROGENATED POLYCYCLOPENTADIENE, SILICA, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), OZOKERITE, ETHYLHEXYL PALMITATE, ISODODECANE, HYDROGENATED POLYISOBUTENE, PARAFFIN, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, DIPALMITOYL HYDROXYPROLINE, CERAMIDE 3, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), BETA-SITOSTEROL, DIMETHICONE, PROPYLPARABEN, LUFFA CYLINDRICA SEED OIL, SILICA SILYLATE, METHYLPARABEN, DISTEARDIMONIUM HECTORITE, PARFUM (FRAGRANCE), PEG-40 HYDROGENATED CASTOR OIL, POLYSORBATE 80, PPG-26-BUTETH-26, BHT, TRIMETHYLSILOXYSILICATE, HEDERA HELIX LEAF/STEM EXTRACT (HEDERA HELIX (IVY) LEAF/STEM EXTRACT), RETINYL PALMITATE, TOCOPHERYL ACETATE, BIOFLAVONOIDS, ALLANTOIN, ASCORBYL PALMITATE. MAY CONTAIN: CI 77019 (MICA), CI 77163 (BISMUTH OXYCHLORIDE), CI 15850 (RED 7 LAKE), CI 77742 (MANGANESE VIOLET), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 19140 (YELLOW 5 LAKE), CI 45380 (RED 21 LAKE), CI 15850 (RED 6 LAKE), CI 45410 (RED 27 LAKE), CI 77499 (IRON OXIDES), CALCIUM SODIUM BOROSILICATE, CI 77492 (IRON OXIDES), TALC, CI 42090 (BLUE 1 LAKE), CI 75470 (CARMINE), C9-15 FLUOROALCOHOL PHOSPHATE, LAUROYL LYSINE.
SPL UNCLASSIFIED SECTION

Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CHAMPAGNE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA SPLENDIDE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE D'AMOUR

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FORMIDABLE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATUREL PERSISTANT

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MIEL ECHANTER

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PRODIGEUX

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRON ILLIMITÉ

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CHOCOLAT MAJESTIC

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CAFÉ SUCCÈS

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE GRANDOISE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE RUBI

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SAUMON ESSENTIEL

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - BOURGOGNE VIF

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIOLET POURPRE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAIL MAXIMUM

COULEUR LUXE AMPLIFIER XP
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4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ORANGE DÉLIRANT

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SPF 15

4 g e (.14 oz.)
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COULEUR LUXE AMPLIFIER XP
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SPF 15

4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE FEMME

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - DORÉ CHOCOLAT

COULEUR LUXE AMPLIFIER XP
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SPF 15

4 g e (.14 oz.)
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PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MER DE ROSES

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SPF 15

4 g e (.14 oz.)
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COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE DÉLICAT

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA DÉSIR

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE PROVOCATION

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - AMPLIFFIER AMANDIER

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - SOBRIETE

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SPF 15

4 g e (.14 oz.)
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SPF 15

4 g e (.14 oz.)
L'BEL
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SPF 15

4 g e (.14 oz.)
L'BEL
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COULEUR LUXE AMPLIFIER XP
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SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NOBLESSE

COULEUR LUXE AMPLIFIER XP
amplifying lipstick
SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MALBEC

COULEUR LUXE AMPLIFIER XP
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SPF 15

4 g e (.14 oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSÉ FUCSIA

COULEUR LUXE AMPLIFIER XP
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SPF 15

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

INGREDIENTS AND APPEARANCE

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE CHAMPAGNE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-305
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Pink pearl)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-305-02	1 in 1 BOX
1	NDC:14783-305-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - FUCSIA SPLENDIDE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-306
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Fuchsia)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-306-02	1 in 1 BOX
1	NDC:14783-306-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE DAMOUR
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-307
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Natural pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-307-02	1 in 1 BOX
1	NDC:14783-307-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE FORMIDABLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-308
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Intense pink pearl)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-308-02	1 in 1 BOX
1	NDC:14783-308-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - NATURAL PERSISTANT
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-309
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Light coffee)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-309-02	1 in 1 BOX
1	NDC:14783-309-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - MIEL ECHANTER
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-310
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Pearl orange coffee)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-310-02	1 in 1 BOX
1	NDC:14783-310-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-311
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-311-02	1 in 1 BOX
1	NDC:14783-311-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - MARRON ILLIMITE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-312
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Maroon)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-312-02	1 in 1 BOX
1	NDC:14783-312-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - CHOCOLAT MAJESTIC
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-313
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Dark brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-313-02	1 in 1 BOX
1	NDC:14783-313-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - CAFE SUCCES
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-314
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Coffee)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-314-02	1 in 1 BOX
1	NDC:14783-314-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-315
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Intense red)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-315-02	1 in 1 BOX
1	NDC:14783-315-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-316
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Intense red pearl)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-316-02	1 in 1 BOX
1	NDC:14783-316-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - SAUMON ESSENTIEL
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-317
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Pearl Salmon red)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-317-02	1 in 1 BOX
1	NDC:14783-317-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - BOURGOGNE VIF
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-318
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Pearl burgundy)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-318-02	1 in 1 BOX
1	NDC:14783-318-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - VIOLET POURPRE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-319
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PURPLE (Pearl dark purple)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-319-02	1 in 1 BOX
1	NDC:14783-319-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - CORAIL MAXIMUM
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-320
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	ORANGE (Light orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-320-02	1 in 1 BOX
1	NDC:14783-320-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-321
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	ORANGE (Intense orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-321-02	1 in 1 BOX
1	NDC:14783-321-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-322
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Intense yellowish red)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-322-02	1 in 1 BOX
1	NDC:14783-322-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE FEMME
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-323
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Pearl bluish pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-323-02	1 in 1 BOX
1	NDC:14783-323-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - DORE CHOCOLAT
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-324
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Pearl copper brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-324-02	1 in 1 BOX
1	NDC:14783-324-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-325
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	YELLOW (Pearl coral gold)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-325-02	1 in 1 BOX
1	NDC:14783-325-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE TENTATION
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-326
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Pearl reddish pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-326-02	1 in 1 BOX
1	NDC:14783-326-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE DELICAT
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-327
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Dark rosewood)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-327-02	1 in 1 BOX
1	NDC:14783-327-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - FUCSIA DESIR
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-328
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Pearl Fuchsia)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-328-02	1 in 1 BOX
1	NDC:14783-328-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-329
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Dark red matte)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-329-02	1 in 1 BOX
1	NDC:14783-329-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - AMPLIFFIER AMANDIER
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-330
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Dark reddish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-330-02	1 in 1 BOX
1	NDC:14783-330-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - SOBRIETE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-331
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Light reddish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-331-02	1 in 1 BOX
1	NDC:14783-331-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - FIANCEE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-332
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Intense pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-332-02	1 in 1 BOX
1	NDC:14783-332-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROMANCE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Dark brown pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-333-02	1 in 1 BOX
1	NDC:14783-333-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - CARMINE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Dark orange red)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-334-02	1 in 1 BOX
1	NDC:14783-334-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - NOBLESSE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-335
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	RED (Pearl red)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-335-02	1 in 1 BOX
1	NDC:14783-335-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - MALBEC
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-336
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	BROWN (Intense reddish coffee)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-336-02	1 in 1 BOX
1	NDC:14783-336-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL COULEUR LUXE AMPLIFIER XP AMPLIFYING SPF 15 - ROSE FUCSIA
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-337
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
CERAMIDE 3 (UNII: 4370DF050B)
SHEA BUTTER (UNII: K49155WL9Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
LAUROYL LYSINE (UNII: 113171Q70B)

Product Characteristics
Color	PINK (Light pearl magenta)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:14783-337-02	1 in 1 BOX
1	NDC:14783-337-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

Labeler - Ventura International LTD. (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-305, 14783-306, 14783-307, 14783-308, 14783-309, 14783-310, 14783-311, 14783-312, 14783-313, 14783-314, 14783-315, 14783-316, 14783-317, 14783-318, 14783-319, 14783-320, 14783-321, 14783-322, 14783-323, 14783-324, 14783-325, 14783-326, 14783-327, 14783-328, 14783-329, 14783-330, 14783-331, 14783-332, 14783-333, 14783-334, 14783-335, 14783-336, 14783-337)

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	NDC
1	14783-305-01
2	14783-305-02 (inactivated)
3	14783-306-01
4	14783-306-02 (inactivated)
5	14783-307-01
6	14783-307-02 (inactivated)
7	14783-308-01
8	14783-308-02 (inactivated)
9	14783-309-01
10	14783-309-02 (inactivated)
11	14783-310-01
12	14783-310-02 (inactivated)
13	14783-311-01
14	14783-311-02 (inactivated)
15	14783-312-01
16	14783-312-02 (inactivated)
17	14783-313-01
18	14783-313-02 (inactivated)
19	14783-314-01
20	14783-314-02 (inactivated)
21	14783-315-01
22	14783-315-02 (inactivated)
23	14783-316-01
24	14783-316-02 (inactivated)
25	14783-317-01
26	14783-317-02 (inactivated)
27	14783-318-01
28	14783-318-02 (inactivated)
29	14783-319-01
30	14783-319-02 (inactivated)
31	14783-320-01
32	14783-320-02 (inactivated)
33	14783-321-01
34	14783-321-02 (inactivated)
35	14783-322-01
36	14783-322-02 (inactivated)
37	14783-323-01
38	14783-323-02 (inactivated)
39	14783-324-01
40	14783-324-02 (inactivated)
41	14783-325-01
42	14783-325-02 (inactivated)
43	14783-326-01
44	14783-326-02 (inactivated)
45	14783-327-01
46	14783-327-02 (inactivated)
47	14783-328-01
48	14783-328-02 (inactivated)
49	14783-329-01
50	14783-329-02 (inactivated)
51	14783-330-01
52	14783-330-02 (inactivated)
53	14783-331-01
54	14783-331-02 (inactivated)
55	14783-332-01
56	14783-332-02 (inactivated)
57	14783-333-01
58	14783-333-02 (inactivated)
59	14783-334-01
60	14783-334-02 (inactivated)
61	14783-335-01
62	14783-335-02 (inactivated)
63	14783-336-01
64	14783-336-02 (inactivated)
65	14783-337-01
66	14783-337-02 (inactivated)

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