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LBEL

Ventura Corporation Ltd.

COULEUR LUXE SUPREME LAQUE liquid lipstick with long duration and shine SPF 16


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate 7 % , Oxybenzone 3%

Purpose

sunscreen

LBEL 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.

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

LBEL

LBEL

OCTINOXATE and OXYBENZONE LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-020
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.07 mL
OXYBENZONE OXYBENZONE 0.03 mL

Inactive Ingredients

Ingredient Name Strength
OCTYLDODECANOL
YELLOW WAX
ISONONYL ISONONANOATE
ISODODECANE
PROPYLENE CARBONATE
PHENOXYETHANOL
ISOSTEARYL ALCOHOL
MICROCRYSTALLINE WAX
petrolatum
BUTYLATED HYDROXYANISOLE
METHYLPARABEN
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
CANDELILLA WAX
carnauba wax
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
isobutylparaben
PROPYLPARABEN
D&C RED NO. 30
ALUMINUM OXIDE
MICA
D&C RED NO. 7
titanium dioxide
FD&C YELLOW NO. 5
D&c Red No. 21
D&C RED NO. 6
talc
LAUROYL LYSINE

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-08-10


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