LBEL- octinoxate and oxybenzone lipstick

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd., BelStar, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7 % , Oxybenzone 3%

Purpose

sunscreen

Uses

Helps prevent sunburn

Warnings

Stop use if skin rash occurs

Inactive ingredients

octyldodecanol, glyceryl hydrogenated rosinate, polybutene, vp/eicosene copolymer, vp/hexadecene copolymer, cera alba (beeswax), isononyl isononanoate, isododecane, silica dimethyl silylate, ethylene/va copolymer, disteardimonium hectorite, propylene carbonate, phenoxyethanol, isostearyl alcohol, cera microcristallina (microcrystalline wax), petrolatum, bha, parfum (fragrance), phospholipids, methylparaben, cholesterol, butylparaben, ethylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), copernicia cerifera cera (copernicia cerifera (carnauba ) wax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, isobutylparaben, propylparaben. May contain: Red 30 lake,,mica, red 7 lake, titanium dioxide, yellow 5 lake, ron oxides, red 21 lake, red 6 lake, talc, lauroyl lysine, carmine, orange 5, triethoxycaprylylsilane, C9-15 fluoroalcohol.

SPL UNCLASSIFIED SECTION

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 7 ml Carton

COULEUR LUXE SUPREME LAQUE

liquid lipstick with long duration and shine SPF 16

7 ml e (.23 fl.oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   COULEUR LUXE SUPREME LAQUE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISODODECANE (UNII: A8289P68Y2)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 6 (UNII: 481744AI4O)
TALC (UNII: 7SEV7J4R1U)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-020-02	1 in 1 CARTON
1	NDC: 13537-020-01	7 mL in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/10/2011

Labeler - Ventura Corporation Ltd. (602751344)

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