LBEL  EFFET PARFAIT ROUGE VOLUMESSE- octinoxate and oxybenzone lipstick 
VENTURA INTERNATIONAL LTD.,

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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L'BEL EFFET PARFAIT ROUGE VOLUMESSE FPS 21

Active Ingredients

Octinoxate (6.72 %), Oxybenzone (2.24 %).

Purpose

Sunscreen.

Uses

Helps prevent sunburn. Moderate 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.

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 (castor) seed oil, caprylic/capric triglyceride, ethylhexyl palmitate, euphorbia cerifera (candelilla) wax, glyceryl isostearate, polyethylene, methyl hydrogenated rosinate, lanolin oil, copernicia cerifera (carnauba) wax, isostearyl alcohol, polybutene, butyrospermum parkii (shea butter), ci 77019 (mica), beta-sitosterol, silica silylate, phenoxyethanol, menthol, octyldodecanol, dimethicone, tribehenin, luffa cylindrica seed oil, propylparaben, methylparaben, cera microcristallina (microcrystalline wax), sorbitan isostearate, parfum (fragance), silica dimethyl silylate, petrolatum, phospholipids, butylparaben, ethylparaben, butylene glycol, cholesterol, isobutylparaben, trimethylsiloxysilicate, cera alba (beewax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, sodium hyaluronate, glycosphingolipids, palmitoyl oligopeptide. May contain: ci 77891 (titanium dioxide), ci 15850:1 (red 7 lake), ci 75470 (carmine), ci 77491, ci 77492, ci 77499 (iron oxides), ci 19140 (yellow 5 lake), ci 45380:2 (red 21 lake), ci 45410:1 (red 27 lake), ci 42090 (blue 1 lake), silica, bht, hydrogenated polyisobutene, palmitic acid, talc.

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

PRINCIPAL DISPLAY PANEL - 4 g Carton

EFFET PARFAIT
ROUGE VOLUMESSE

maximum volume effect lipstick spf 21

4 g e (.14 oz.)

L'BEL

Principal Display Panel - 4 g Carton
LBEL   EFFET PARFAIT ROUGE VOLUMESSE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.2688 g  in 4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0896 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
castor oil (UNII: D5340Y2I9G)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
ethylhexyl palmitate (UNII: 2865993309)  
candelilla wax (UNII: WL0328HX19)  
lanolin (UNII: 7EV65EAW6H)  
carnauba wax (UNII: R12CBM0EIZ)  
isostearyl alcohol (UNII: Q613OCQ44Y)  
shea butter (UNII: K49155WL9Y)  
mica (UNII: V8A1AW0880)  
.beta.-sitosterol (UNII: S347WMO6M4)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
phenoxyethanol (UNII: HIE492ZZ3T)  
menthol (UNII: L7T10EIP3A)  
octyldodecanol (UNII: 461N1O614Y)  
dimethicone (UNII: 92RU3N3Y1O)  
tribehenin (UNII: 8OC9U7TQZ0)  
luffa (UNII: F0R3Y60C6V)  
propylparaben (UNII: Z8IX2SC1OH)  
methylparaben (UNII: A2I8C7HI9T)  
sorbitan (UNII: 6O92ICV9RU)  
petrolatum (UNII: 4T6H12BN9U)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylene glycol (UNII: 3XUS85K0RA)  
cholesterol (UNII: 97C5T2UQ7J)  
isobutylparaben (UNII: 0QQJ25X58G)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
titanium dioxide (UNII: 15FIX9V2JP)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
aluminum oxide (UNII: LMI26O6933)  
ferric oxide red (UNII: 1K09F3G675)  
ferric oxide yellow (UNII: EX438O2MRT)  
ferrosoferric oxide (UNII: XM0M87F357)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
palmitic acid (UNII: 2V16EO95H1)  
talc (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-220-621 in 1 BOX
1NDC:13537-220-614 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
Labeler - VENTURA INTERNATIONAL LTD., (602751344)

Revised: 8/2010
Document Id: 11ff77dd-09ef-475a-99fb-db685389c6e6
Set id: e031525f-942c-4404-af8c-b5278a03aa77
Version: 1
Effective Time: 20100810
 
VENTURA INTERNATIONAL LTD.,