LBEL  EFFET PARFAIT ROUGE ALISSANT- 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 Alissant SPF17

Active Ingredients

Octinoxate (6.0 %), Oxybenzone (1.5 %).

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

Methyl hydrogenated rosinate, diisopropyl dimer dilinoleate, myristyl myristate,myristyl myristate, castor isostearate beeswax succinate, cera alba (beeswax), copernicia cerifera(carnauba) wax, disteardimonium hectorite, dipalmitoyl hydroxyproline, silica silylate, octyldodecanol, menthoxypropanediol, cera microcristallina (microcrystalline wax), propylparaben, methylparaben, parfum (fragance), petrolatum, phospholipids, bht, cholesterol, polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, cetearyl glucoside, cetearyl alcohol, glycosphingolipids. May contain: ci 77019 (mica), ci 77891 (titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides), silica, ci 75470 (carmine), calcium aluminum borosilicate, tin oxide, ricinus communis (castor) seed oil, ci 42090 (blue 1 lake), talc, ci 15850:1 (red 7 lake), ci 19140 (yellow 5 lake), ci 45380:2 (red 21 lake), ci 45410:1 (red 27 lake).

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

PRINCIPAL DISPLAY PANEL - 4 g Carton

EFFET PARFAIT
ROUGE ALISSANT

lipstick wrinkle minimizer effect spf 17

4 g e (.14 oz.)

L'BEL

Principal Display Panel - 4 g Carton
LBEL   EFFET PARFAIT ROUGE ALISSANT
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.24 g  in 4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
myristyl myristate (UNII: 4042ZC00DY)  
yellow wax (UNII: 2ZA36H0S2V)  
carnauba wax (UNII: R12CBM0EIZ)  
hectorite (UNII: 08X4KI73EZ)  
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
octyldodecanol (UNII: 461N1O614Y)  
propylparaben (UNII: Z8IX2SC1OH)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
cholesterol (UNII: 97C5T2UQ7J)  
candelilla wax (UNII: WL0328HX19)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
ferric oxide red (UNII: 1K09F3G675)  
ferric oxide yellow (UNII: EX438O2MRT)  
ferrosoferric oxide (UNII: XM0M87F357)  
tin (UNII: 387GMG9FH5)  
castor oil (UNII: D5340Y2I9G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
aluminum oxide (UNII: LMI26O6933)  
talc (UNII: 7SEV7J4R1U)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-011-621 in 1 BOX
1NDC:13537-011-614 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: 0da5028f-027d-401e-8bbb-cbb5ca204e01
Set id: 37196036-229e-4061-8379-cf440b15275c
Version: 1
Effective Time: 20100810
 
VENTURA INTERNATIONAL LTD.,