LBEL  COULEUR LUXE ROUGE IRRESISTIBLE- octinoxate and oxybenzone lipstick 
Ventura International, Limited

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
COULEUR LUXE ROUGE IRRÉSISTIBLE
maximum hydration lipstick SPF 17

Active Ingredients

Octinoxate 7.1 % , Oxybenzone 1.6%

Purpose

sunscreen

Uses

Helps prevent sunburn

Warnings

Stop use if skin rash occurs

Inactive ingredients

ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, polymethyl methacrylate, (butyrospermum parkii (shea butter), ozokerite, copernicia cerifera (carnauba) wax, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, octyldodecanol, disteardimonium hectorite, caprylic/capric triglyceride, phenoxyethanol, tocopheryl acetate, aloe barbadensis leaf extract, fragrance, microcrystalline wax, propylene carbonate, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, propylparaben, isobutylparaben, glycosphingolipids. May contain: mica, titanium dioxide, red 7 lake, iron oxides, yellow 5 lake, red 30 lake, red 21 lake, bismuth oxychloride, talc, red 40 lake, blue 1 lake, carmine, hydrogenated polyisobutene, palmitic acid.

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 4 g Carton

COULEUR LUXE ROUGE IRRÉSISTIBLE

maximum hydration lipstick SPF 17

4 g e (.14 oz.)

L'BEL

Principal Display Panel - 4 g Carton
LBEL   COULEUR LUXE ROUGE IRRESISTIBLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-990
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.016 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERESIN (UNII: Q1LS2UJO3A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
TALC (UNII: 7SEV7J4R1U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PALMITIC ACID (UNII: 2V16EO95H1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-990-0512 in 1 CARTON
1NDC:14783-990-044 g in 1 TUBE
2NDC:14783-990-1212 in 1 CARTON
2NDC:14783-990-1111.4 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/26/2010
Labeler - Ventura International, Limited (603192787)
Establishment
NameAddressID/FEIBusiness Operations
BelStar, S.A.880160197MANUFACTURE

Revised: 11/2010
Document Id: c55866be-7df4-4214-b7c5-3cb3de98d9f2
Set id: 24769ced-baf8-48b4-abbc-c390484e2ce9
Version: 1
Effective Time: 20101110
 
Ventura International, Limited