Active Ingredients

Octinoxate 0.98%, Oxybenzone 0.47%, Titanium Dioxide 0.94%.

Purpose

Sunscreen.

Uses

Helps prevent sunburn.

Warnings

Stop use and ask doctor if rash or irritation develops and lasts.

Directions

Apply smoothly before sun exposure and as needed. Minimal sun protection product.

Inactive ingredients

ricinus communis seed oil (ricinus communis (castor) seed oil), diisostearyl malate, caprylic/capric triglyceride, decyl oleate, ozokerite, cera alba (beeswax), copernicia cerifera cera (copernicia cerifera (carnauba) wax), candelilla cera (euphorbia cerifera (candelilla) wax), isopropyl lanolate, sorbitan sesquioleate, CI 77019 (mica), hydrogenated polyisobutene, vp/hexadecene copolymer, isostearyl neopentanoate, octyldodecanol, parfum (fragrance), propylparaben, lecithin, bht, dimethicone, arachidyl propionate, tocopheryl acetate, retinyl palmitate, trimethylsiloxysilicate, ethyl linoleate, ethyl linolenate. may contain: CI 77891 (titanium dioxide), CI 77163 (bismuth oxychloride), CI 19140 (yellow 5 lake), CI 15850 (red 6 lake), CI 45410 (red 27 lake), CI 15850 (red 7 lake), CI 77491, CI 77492, CI 77499 (iron oxides), CI 45380 (red 21 lake), oleyl alcohol, talc, C9-13 fluoroalcohol, phosphoric acid, CI 75470 (carmine).

PRINCIPAL DISPLAY PANEL - 11.1 g Kit

COFFRET COULEUR

makeup palette for the face, eyes and lips

11,1 g e (.38 oz.)

This palette contains:

L'Bel Couleur Luxe Supreme XP / lipstick with long duration and shine SPF 8
L'Bel Coffret Couleur / eyeshadow quartet
L'Bel Couleur luxe Blush Delicat xp / compact blusher
L'Bel Gloss Coffret Couleur / lip gloss

L'BEL

PRINCIPAL DISPLAY PANEL - 11.1 g Kit

COFFRET COULEUR

makeup palette for the face, eyes and lips

11,1 g e (.38 oz.)

This palette contains:

L'Bel Couleur Luxe Supreme XP / lipstick with long duration and shine SPF 8
L'Bel Coffret Couleur / eyeshadow quartet
L'Bel Couleur luxe Blush Delicat xp / compact blusher
L'Bel Gloss Coffret Couleur / lip gloss

L'BEL

LBEL COULER LUXE SUPREME XP ROSACE, EXCENTRIQUE, HARMONIE
octinoxate, oxybenzone, and titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-660
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0098 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0047 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0094 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DECYL OLEATE (UNII: ZGR06DO97T)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MICA (UNII: V8A1AW0880)
OCTYLDODECANOL (UNII: 461N1O614Y)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 17 (UNII: ND733RX3JN)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
TALC (UNII: 7SEV7J4R1U)
PHOSPHORIC ACID (UNII: E4GA8884NN)

#	Item Code	Package Description
Packaging
1	NDC:14783-660-12	3 in 1 KIT
1	NDC:14783-660-11	0.7 g in 1 TRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	11/26/2010

LBEL COULER LUXE SUPREME XP SUBLIME, ORANGE, SOBRIETE
octinoxate, oxybenzone, and titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-661
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0098 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0047 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0094 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DECYL OLEATE (UNII: ZGR06DO97T)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MICA (UNII: V8A1AW0880)
OCTYLDODECANOL (UNII: 461N1O614Y)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 17 (UNII: ND733RX3JN)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
TALC (UNII: 7SEV7J4R1U)
PHOSPHORIC ACID (UNII: E4GA8884NN)

#	Item Code	Package Description
Packaging
1	NDC:14783-661-12	3 in 1 KIT
1	NDC:14783-661-11	0.7 g in 1 TRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	11/26/2010

Labeler - Ventura International, Limited (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
BelStar, S.A.		880160197	MANUFACTURE