LBEL- octinoxate and oxybenzone lipstick

LBel by

Drug Labeling and Warnings

LBel by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate (4.6 %), Oxybenzone (0.9 %)

Purpose

Sunscreen

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.

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LBEL   COULEUR LUXE ROUGE AMPLIFIER XP
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.18 g  in 4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0036 g  in 4 g

Inactive Ingredients
Ingredient Name	Strength
carnauba wax (UNII: R12CBM0EIZ)
candelilla wax (UNII: WL0328HX19)
ethylhexyl palmitate (UNII: 2865993309)
isododecane (UNII: A8289P68Y2)
paraffin (UNII: I9O0E3H2ZE)
isostearyl alcohol (UNII: Q613OCQ44Y)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
shea butter (UNII: K49155WL9Y)
.beta.-sitosterol (UNII: S347WMO6M4)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
polysorbate 80 (UNII: 6OZP39ZG8H)
kalmia latifolia leaf (UNII: 79N6542N18)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
allantoin (UNII: 344S277G0Z)
D&C red no. 21 (UNII: 08744Z6JNY)
Aluminum Oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
D&C red no. 6 (UNII: 481744AI4O)
FD&C yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
talc (UNII: 7SEV7J4R1U)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

Labeler - Ventura International LTD (603192787)