DailyMed - LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE NATURAL) - BROWN- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROJO VIF) - BROWN- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (MOKA) - PINK- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (MANDARINE) - PURPLE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (CAPUCCINO) - PURPLE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (VIN) - PURPLE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (FUCHSIA INTENSE) - PURPLE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROUGE BRILLANCE) - BROWN- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROUGE INTENSE) - PURPLE- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (FUCHSIA BRILLANCE) - RED- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE BRILLANCE) - RED- octinoxate and oxybenzone lipstick LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE CLASSIQUE)

Contains inactivated NDC Code(s)
NDC Code(s): 13537-100-01, 13537-100-02, 13537-101-03, 13537-101-04, view more
13537-102-07, 13537-102-08, 13537-103-09, 13537-103-10, 13537-104-11, 13537-104-12, 13537-105-13, 13537-105-14, 13537-106-15, 13537-106-16, 13537-107-17, 13537-107-18, 13537-108-19, 13537-108-20, 13537-109-21, 13537-109-22, 13537-111-23, 13537-111-24, 13537-443-05, 13537-443-06
Packager: Ventura Corporation LTD

Category: HUMAN OTC DRUG LABEL

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 February 3, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate (7.1%) Sunscreen

Oxybenzone (1.6%) Sunscreen
Uses
- Helps prevent sunburn.
Warnings
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes.Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
Other information
- Protect this product in this container form excesive heat and direct sun.
Inactive ingredients

Ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, ozokerite, butyrospermum parkii (shea butter), tridecyl stearate, copernicia cerifera cera (carnauba) wax, polymethyl methacrylate, neopentyl glycol dicaprylate/dicaprate, disteardimonium hectorite, octyldodecanol, caprylic/capric triglyceride, phenoxyethanol, propylene carbonate, tocopheryl acetate, parfum (fragrance),microcrystalline wax, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, propylparaben, aloe barbadensis leaf extract, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, glycosphingolipids.

May contain:
Mica , red 7 lake , iron oxides, titanium dioxide , red 30 lake, yellow 5 lake , red 21 lake , bismuth oxychloride, red 40 lake , talc, blue 1 lake , hydrogenated polyisobutene, carmine, palmitic acid.
SPL UNCLASSIFIED SECTION

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE NATURAL - BROWN

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO VIF - BROWN

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MOKA - PINK

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MANDARINE - PURPLE

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CAPUCCINO - PURPLE

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIN - PURPLE

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCHSIA INTENSE - PURPLE

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE BRILLANCE - BROWN

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE - PURPLE

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCHSIA BRILLANCE - RED

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE BRILLANCE - RED

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CLASSIQUE - RED

COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Net Weight 0.14 oz. (4 g)

L'BEL

Active Ingredients	Purpose
Octinoxate (7.1%)	Sunscreen
Oxybenzone (1.6%)	Sunscreen

INGREDIENTS AND APPEARANCE

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE NATURAL) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-100-02	1 in 1 BOX
1	NDC:13537-100-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROJO VIF) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-101-04	1 in 1 BOX
1	NDC:13537-101-03	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (MOKA) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-443
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-443-06	1 in 1 BOX
1	NDC:13537-443-05	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (MANDARINE) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-102-08	1 in 1 BOX
1	NDC:13537-102-07	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (CAPUCCINO) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-103-10	1 in 1 BOX
1	NDC:13537-103-09	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (VIN) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-104-12	1 in 1 BOX
1	NDC:13537-104-11	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (FUCHSIA INTENSE) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-105-14	1 in 1 BOX
1	NDC:13537-105-13	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROUGE BRILLANCE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-106-16	1 in 1 BOX
1	NDC:13537-106-15	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROUGE INTENSE) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-107
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-107-18	1 in 1 BOX
1	NDC:13537-107-17	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (FUCHSIA BRILLANCE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-108-20	1 in 1 BOX
1	NDC:13537-108-19	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE BRILLANCE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-109
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-109-22	1 in 1 BOX
1	NDC:13537-109-21	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

LBEL COULEUR LUXE ROUGE IRRESISTIBLE MAXIMUM HYDRATION SPF 17 (ROSE CLASSIQUE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.016 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ethylhexyl palmitate (UNII: 2865993309)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
high density polyethylene (UNII: UG00KM4WR7)
shea butter (UNII: K49155WL9Y)
tridecyl stearate (UNII: A8OE252M6L)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
disteardimonium hectorite (UNII: X687XDK09L)
octyldodecanol (UNII: 461N1O614Y)
medium-chain triglycerides (UNII: C9H2L21V7U)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
microcrystalline wax (UNII: XOF597Q3KY)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
propylparaben (UNII: Z8IX2SC1OH)
aloe vera leaf (UNII: ZY81Z83H0X)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylated hydroxyanisole (UNII: REK4960K2U)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
isobutylparaben (UNII: 0QQJ25X58G)
mica (UNII: V8A1AW0880)
d&c red no. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 30 (UNII: 2S42T2808B)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 21 (UNII: 08744Z6JNY)
bismuth oxychloride (UNII: 4ZR792I587)
fd&c red no. 40 (UNII: WZB9127XOA)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
palmitic acid (UNII: 2V16EO95H1)

#	Item Code	Package Description
Packaging
1	NDC:13537-111-24	1 in 1 BOX
1	NDC:13537-111-23	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/31/2014

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-100, 13537-101, 13537-443, 13537-102, 13537-103, 13537-104, 13537-105, 13537-106, 13537-107, 13537-108, 13537-109, 13537-111)

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	NDC
1	13537-100-01
2	13537-100-02 (inactivated)
3	13537-101-03
4	13537-101-04 (inactivated)
5	13537-102-07
6	13537-102-08 (inactivated)
7	13537-103-09
8	13537-103-10 (inactivated)
9	13537-104-11
10	13537-104-12 (inactivated)
11	13537-105-13
12	13537-105-14 (inactivated)
13	13537-106-15
14	13537-106-16 (inactivated)
15	13537-107-17
16	13537-107-18 (inactivated)
17	13537-108-19
18	13537-108-20 (inactivated)
19	13537-109-21
20	13537-109-22 (inactivated)
21	13537-111-23
22	13537-111-24 (inactivated)
23	13537-443-05
24	13537-443-06 (inactivated)

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Number of versions: 1

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.