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LBel

Ventura International LTD

COULEUR LUXE SUPREME XP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate (0.98 %), Oxybenzone (0.47 %), Titanium Dioxide (0.94 %).

Purpose

Sunscreen.

LBel Uses

Helps prevent sunburn. Minimum 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 seed oil (ricinus communis (castor) seed oil), diisostearyl malate, caprylic/capric truglyceride, decyl oleate, ci 77019 (mica), ozokerite, cera alba (beeswax), copernicia cerifera ( copernicia cerifera (carnauba)wax), candelilla cera (euphorbia cerifera (candelilla) wax), isopropyl lanolate, sorbitan sesquioleate, hydrogenated polyisobutene, vp/hexadecene copolymer, isostearyl neopentanoate, octyldodecano, parfum (fragance), propylparaben, lecithin, bht, dimethicone, arachidyl propionate, tocopheryl acetate, retinyl palmitate, trimethylsiloxysilicate, ethyl linoleate, ethyl linolenate. May contain: ci 77891 (titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides), ci 77163 (bismuth oxychloride), ci 15850 (red 6 lake), ci 19140 (yellow 5 lake), ci 15850 (red 7 lake), ci 45410 (red 27 lake), ci 45380 (red 21 lake), talc, ci 42090 (blue 1 lake), oleyl alcohol, c9-13 fluoroalcohol, phosphoric acid, ci 75470 (carmine).

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

PRINCIPAL DISPLAY PANEL - 4 g Carton

COULEUR LUXE SUPRÊME XP

lipstick with long duration and shine spf 8

4 g e (.14 oz.)

L'BEL

LBel

LBel

Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-083
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.0392 g
OXYBENZONE OXYBENZONE 0.0188 g
titanium dioxide 0.0376 g

Inactive Ingredients

Ingredient Name Strength
castor oil
MEDIUM-CHAIN TRIGLYCERIDES
DECYL OLEATE
YELLOW WAX
carnauba wax
CANDELILLA WAX
SORBITAN SESQUIOLEATE
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
DIMETHICONE
ARACHIDYL PROPIONATE
VITAMIN A PALMITATE
ETHYL LINOLEATE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
D&C RED NO. 6
FD&C YELLOW NO. 5
D&C RED NO. 28
talc
FD&C BLUE NO. 1
OLEYL ALCOHOL
phosphoric acid
MICA
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-083-61 4 in 1 TUBE
2 NDC:14783-083-62 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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