LBEL  COULEUR LUXE SUPREME XP- octinoxate, oxybenzone, and titanium dioxide 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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COULEUR LUXE SUPREME XP

Active Ingredients

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

Purpose

Sunscreen.

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.

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

Principal Display Panel - 4 g Carton
LBEL   COULEUR LUXE SUPREME XP
octinoxate, oxybenzone, and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0392 g  in 4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0188 g  in 4 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0376 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
castor oil (UNII: D5340Y2I9G)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
decyl oleate (UNII: ZGR06DO97T)  
yellow wax (UNII: 2ZA36H0S2V)  
carnauba wax (UNII: R12CBM0EIZ)  
candelilla wax (UNII: WL0328HX19)  
sorbitan sesquioleate (UNII: 0W8RRI5W5A)  
propylparaben (UNII: Z8IX2SC1OH)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
dimethicone (UNII: 92RU3N3Y1O)  
arachidyl propionate (UNII: QV5DAH3MSB)  
vitamin a palmitate (UNII: 1D1K0N0VVC)  
ethyl linoleate (UNII: MJ2YTT4J8M)  
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)  
D&C red no. 28 (UNII: 767IP0Y5NH)  
talc (UNII: 7SEV7J4R1U)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
oleyl alcohol (UNII: 172F2WN8DV)  
phosphoric acid (UNII: E4GA8884NN)  
mica (UNII: V8A1AW0880)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-083-621 in 1 BOX
1NDC:14783-083-614 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 (603192787)

Revised: 8/2010
Document Id: 84e83063-f93c-4935-a846-5bb9decb9ebe
Set id: 461d2d02-4960-453a-807d-42a47623b92a
Version: 1
Effective Time: 20100810
 
Ventura International LTD