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LBel Couleur Luxe Supreme XP

Dosage form: lipstick
Ingredients: Octinoxate 0.0392g in 4g, Oxybenzone 0.0188g in 4g, Titanium Dioxide 0.0376g in 4g
Labeler: Ventura International LTD
NDC Code: 14783-083

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.

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

LBEL   COULEUR LUXE SUPREME XP
octinoxate, oxybenzone, and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-083
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.0392 g  in 4 g
Oxybenzone (Oxybenzone) Oxybenzone0.0188 g  in 4 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide0.0376 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
castor oil 
medium-chain triglycerides 
decyl oleate 
yellow wax 
carnauba wax 
candelilla wax 
sorbitan sesquioleate 
propylparaben 
butylated hydroxytoluene 
dimethicone 
arachidyl propionate 
vitamin a palmitate 
ethyl linoleate 
ferric oxide red 
ferric oxide yellow 
ferrosoferric oxide 
D&C red no. 6 
FD&C yellow no. 5 
D&C red no. 28 
talc 
FD&C blue no. 1 
oleyl alcohol 
phosphoric acid 
mica 
aluminum oxide 
Packaging
#Item CodePackage Description
1NDC:14783-083-621 TUBE (TUBE) 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)

 
Ventura International LTD

Medically reviewed on Aug 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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