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LBel

Ventura International LTD

COULEUR LUXE ROUGE AMPLIFIER XP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate (4.6 %), Oxybenzone (0.9 %)

Purpose

Sunscreen

LBel Uses

Helps prevent sunburn.

Warnings

Stop use if skin rash occurs.

Directions

Apply smoothly every morning before sun exposure and as needed. Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil. Children under 6 months of age: ask a doctor. Moderate sun protection product.

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

Diisopropyl dimer dilinoleate, methyl hydrogenated rosinate, isostearyl neopentanoate, castor isostearate beeswax succinate, ci 77019 (mica), ethylhexyl methoxycinnamate, hydrogenated polycyclopentadiene, polyethylene, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ozokerite, ethylhexyl palmitate, isododecane, paraffin, hydrogenated polyisobutene, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, benzophenone-3, ceramide 3, butyrospermum parkii (shea butter), beta-sitosterol, dimethicone, silica silylate, luffa cylindrica seed oil, silica, propylparaben, methylparaben, disteardimonium hectorite, ppg-26-buteth-26, peg-40 hydrogenated castor oil, polysorbate 80, parfum (fragance), hedera helix (ivy) leaf/stem extract, trimethylsiloxysilicate, bht, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, bioflavonoids, allantoin. May contain: ci 45380:2 (red 21 lake), ci 77491, ci 77492, ci 77499 (iron oxides), ci 15850:1 (red 7 lake), ci 19140 (yellow 5 lake), ci 77891 (titanium dioxide), ci 77163 (bismuth xychloride), talc.

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

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Carton

COULEUR LUXE ROUGE AMPLIFIER XP

amplifying lipstick spf 15

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:14783-081
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.18 g
OXYBENZONE OXYBENZONE 0.0036 g

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CANDELILLA WAX
ETHYLHEXYL PALMITATE
ISODODECANE
PARAFFIN
ISOSTEARYL ALCOHOL
DIPALMITOYL HYDROXYPROLINE
SHEA BUTTER
.BETA.-SITOSTEROL
DIMETHICONE
SILICON DIOXIDE
PROPYLPARABEN
METHYLPARABEN
POLYOXYL 40 HYDROGENATED CASTOR OIL
polysorbate 80
kalmia latifolia leaf
BUTYLATED HYDROXYTOLUENE
VITAMIN A PALMITATE
ASCORBYL PALMITATE
ALLANTOIN
D&c Red No. 21
ALUMINUM OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
D&C RED NO. 6
FD&C YELLOW NO. 5
titanium dioxide
talc

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-081-61 4 in 1 TUBE
2 NDC:14783-081-62 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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