LBel Couleur Luxe Rouge Amplifier XP

Dosage form: lipstick
Ingredients: Octinoxate 0.18g in 4g, Oxybenzone 0.0036g in 4g
Labeler: Ventura International LTD
NDC Code: 14783-081

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 ROUGE AMPLIFIER XP

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.

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

LBEL   COULEUR LUXE ROUGE AMPLIFIER XP
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-081
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.18 g  in 4 g
Oxybenzone (Oxybenzone) Oxybenzone0.0036 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
candelilla wax 
ethylhexyl palmitate 
isododecane 
paraffin 
isostearyl alcohol 
dipalmitoyl hydroxyproline 
shea butter 
.beta.-sitosterol 
dimethicone 
silicon dioxide 
propylparaben 
methylparaben 
polyoxyl 40 hydrogenated castor oil 
polysorbate 80 
kalmia latifolia leaf 
butylated hydroxytoluene 
vitamin a palmitate 
ascorbyl palmitate 
allantoin 
D&C red no. 21 
Aluminum Oxide 
ferric oxide red 
ferric oxide yellow 
ferrosoferric oxide 
D&C red no. 6 
FD&C yellow no. 5 
titanium dioxide 
talc 
Packaging
#Item CodePackage Description
1NDC:14783-081-621 TUBE (TUBE) in 1 BOX
1NDC:14783-081-614 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: 08/2010
 
Ventura International LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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