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LBel

VENTURA INTERNATIONAL LTD.,

L'BEL EFFET PARFAIT ROUGE VOLUMESSE FPS 21


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

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

Purpose

Sunscreen.

LBel 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.

LBel 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.

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

LBel

LBel

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-220
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.2688 g
OXYBENZONE OXYBENZONE 0.0896 g

Inactive Ingredients

Ingredient Name Strength
castor oil
MEDIUM-CHAIN TRIGLYCERIDES
ETHYLHEXYL PALMITATE
CANDELILLA WAX
LANOLIN
carnauba wax
ISOSTEARYL ALCOHOL
SHEA BUTTER
MICA
.BETA.-SITOSTEROL
SILICON DIOXIDE
PHENOXYETHANOL
MENTHOL
OCTYLDODECANOL
DIMETHICONE
tribehenin
luffa
PROPYLPARABEN
METHYLPARABEN
SORBITAN
petrolatum
BUTYLPARABEN
ETHYLPARABEN
BUTYLENE GLYCOL
CHOLESTEROL
isobutylparaben
YELLOW WAX
CETOSTEARYL ALCOHOL
HYALURONATE SODIUM
titanium dioxide
D&C RED NO. 7
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FD&C YELLOW NO. 5
D&c Red No. 21
D&C RED NO. 27
FD&C BLUE NO. 1
BUTYLATED HYDROXYTOLUENE
PALMITIC ACID
talc

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-08-15


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