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LBEL

Ventura Corporation Ltd.

L'BEL COULEUR LUXE ROUGE IRRÉSISTIBLE maximum hydration lipstick SPF 17


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate 7.1 % , Oxybenzone 1.6%

Purpose

sunscreen

LBEL Uses

Helps prevent sunburn

Warnings

Stop use if skin rash occurs

Inactive ingredients

ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, polymethyl methacrylate, (butyrospermum parkii (shea butter), ozokerite, copernicia cerifera (carnauba) wax, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, octyldodecanol, disteardimonium hectorite, caprylic/capric triglyceride, phenoxyethanol, tocopheryl acetate, aloe barbadensis leaf extract, fragrance, microcrystalline wax, propylene carbonate, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, propylparaben, isobutylparaben, glycosphingolipids. May contain: mica, titanium dioxide, red 7 lake, iron oxides, yellow 5 lake, red 30 lake, red 21 lake, bismuth oxychloride, talc, red 40 lake, blue 1 lake, carmine, hydrogenated polyisobutene, palmitic acid.

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 - 4 g Carton

COULEUR LUXE ROUGE IRRÉSISTIBLE

maximum hydration lipstick SPF 17

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:13537-019
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
ETHYLHEXYL PALMITATE
SHEA BUTTER
Ceresin
carnauba wax
TRIDECYL STEARATE
OCTYLDODECANOL
MEDIUM-CHAIN TRIGLYCERIDES
PHENOXYETHANOL
Aloe Vera Leaf
MICROCRYSTALLINE WAX
PROPYLENE CARBONATE
SILICON DIOXIDE
METHYLPARABEN
petrolatum
BUTYLATED HYDROXYTOLUENE
CHOLESTEROL
BUTYLPARABEN
ETHYLPARABEN
BUTYLATED HYDROXYANISOLE
CANDELILLA WAX
YELLOW WAX
CETEARYL GLUCOSIDE
CETOSTEARYL ALCOHOL
PROPYLPARABEN
isobutylparaben
MICA
titanium dioxide
ALUMINUM OXIDE
D&C RED NO. 7
ferric oxide red
FERRIC OXIDE YELLOW
FD&C YELLOW NO. 5
D&C RED NO. 30
D&c Red No. 21
BISMUTH OXYCHLORIDE
talc
FD&C RED NO. 40
D&C BLUE NO. 4
FD&C BLUE NO. 1
PALMITIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-019-01 4 in 1 TUBE
2 NDC:13537-019-03 11.4 in 1 TRAY
3 NDC:13537-019-04 12 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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