LBEL- octinoxate and oxybenzone lipstick

LBel by

Drug Labeling and Warnings

LBel by is a Otc medication manufactured, distributed, or labeled by VENTURA INTERNATIONAL LTD.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate (6.72 %), Oxybenzone (2.24 %).

Purpose

Sunscreen.

Uses

Helps prevent sunburn. Moderate sun protection product.

Warnings

Stop use if skin rash occurs.

Directions

Apply evenly before sun exposure and as needed. Apply lipstick following the curves of natural lip line.For added definition, use with a lip pencil.

Other information

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Ricinus communis (castor) seed oil, caprylic/capric triglyceride, ethylhexyl palmitate, euphorbia cerifera (candelilla) wax, glyceryl isostearate, polyethylene, methyl hydrogenated rosinate, lanolin oil, copernicia cerifera (carnauba) wax, isostearyl alcohol, polybutene, butyrospermum parkii (shea butter), ci 77019 (mica), beta-sitosterol, silica silylate, phenoxyethanol, menthol, octyldodecanol, dimethicone, tribehenin, luffa cylindrica seed oil, propylparaben, methylparaben, cera microcristallina (microcrystalline wax), sorbitan isostearate, parfum (fragance), silica dimethyl silylate, petrolatum, phospholipids, butylparaben, ethylparaben, butylene glycol, cholesterol, isobutylparaben, trimethylsiloxysilicate, cera alba (beewax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, sodium hyaluronate, glycosphingolipids, palmitoyl oligopeptide. May contain: ci 77891 (titanium dioxide), ci 15850:1 (red 7 lake), ci 75470 (carmine), ci 77491, ci 77492, ci 77499 (iron oxides), ci 19140 (yellow 5 lake), ci 45380:2 (red 21 lake), ci 45410:1 (red 27 lake), ci 42090 (blue 1 lake), silica, bht, hydrogenated polyisobutene, palmitic acid, talc.

SPL UNCLASSIFIED SECTION

US: Distributed by Ventura International, Ltd. San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 4 g Carton

EFFET PARFAIT
ROUGE VOLUMESSE

maximum volume effect lipstick spf 21

4 g e (.14 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT ROUGE VOLUMESSE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.2688 g  in 4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0896 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
castor oil (UNII: D5340Y2I9G)
medium-chain triglycerides (UNII: C9H2L21V7U)
ethylhexyl palmitate (UNII: 2865993309)
candelilla wax (UNII: WL0328HX19)
lanolin (UNII: 7EV65EAW6H)
carnauba wax (UNII: R12CBM0EIZ)
isostearyl alcohol (UNII: Q613OCQ44Y)
shea butter (UNII: K49155WL9Y)
mica (UNII: V8A1AW0880)
.beta.-sitosterol (UNII: S347WMO6M4)
silicon dioxide (UNII: ETJ7Z6XBU4)
phenoxyethanol (UNII: HIE492ZZ3T)
menthol (UNII: L7T10EIP3A)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
tribehenin (UNII: 8OC9U7TQZ0)
luffa (UNII: F0R3Y60C6V)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
sorbitan (UNII: 6O92ICV9RU)
petrolatum (UNII: 4T6H12BN9U)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
butylene glycol (UNII: 3XUS85K0RA)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
palmitic acid (UNII: 2V16EO95H1)
talc (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-220-62	1 in 1 BOX
1	NDC: 13537-220-61	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

Labeler - VENTURA INTERNATIONAL LTD., (602751344)