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 (6.0 %), Oxybenzone (1.5 %).

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

Methyl hydrogenated rosinate, diisopropyl dimer dilinoleate, myristyl myristate,myristyl myristate, castor isostearate beeswax succinate, cera alba (beeswax), copernicia cerifera(carnauba) wax, disteardimonium hectorite, dipalmitoyl hydroxyproline, silica silylate, octyldodecanol, menthoxypropanediol, cera microcristallina (microcrystalline wax), propylparaben, methylparaben, parfum (fragance), petrolatum, phospholipids, bht, cholesterol, polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, cetearyl glucoside, cetearyl alcohol, glycosphingolipids. May contain: ci 77019 (mica), ci 77891 (titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides), silica, ci 75470 (carmine), calcium aluminum borosilicate, tin oxide, ricinus communis (castor) seed oil, ci 42090 (blue 1 lake), talc, ci 15850:1 (red 7 lake), ci 19140 (yellow 5 lake), ci 45380:2 (red 21 lake), ci 45410:1 (red 27 lake).

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 g Carton

EFFET PARFAIT
ROUGE ALISSANT

lipstick wrinkle minimizer effect spf 17

4 g e (.14 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT ROUGE ALISSANT
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.24 g  in 4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.06 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
myristyl myristate (UNII: 4042ZC00DY)
yellow wax (UNII: 2ZA36H0S2V)
carnauba wax (UNII: R12CBM0EIZ)
hectorite (UNII: 08X4KI73EZ)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
candelilla wax (UNII: WL0328HX19)
cetostearyl alcohol (UNII: 2DMT128M1S)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
tin (UNII: 387GMG9FH5)
castor oil (UNII: D5340Y2I9G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
talc (UNII: 7SEV7J4R1U)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-011-62	1 in 1 BOX
1	NDC: 13537-011-61	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)