LBEL  SUPREMACIE TEINT- octinoxate cream 
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
SUPRÉMACIE TEINT

Drug Facts

Active Ingredients

Octinoxate (4.5 %)

Purpose

Sunscreen

Uses

Warnings

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash and irritation develops and lasts.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aqua (water), cyclopentasiloxane, butylene glycol, cyclohexasiloxane, phenyl trimethicone, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, polydodecanamideaminium triazadiphenylethenesulfonate, hexyl laurate, mannitol, glycerin, peg/ppg-18/18 dimethicone, glycine soja (soybean) protein, ethylene/acrylic acid copolymer, sodium chloride, disteardimonium hectorite, dimethicone, propylene glycol, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, diazolidinyl urea, hydrolyzed keratin, dimethiconol, sucrose, methylparaben, serine, parfum (fragance), methicone, arginine, cyclodextrin, polyvinylalcohol crosspolymer, pca, bht, macrocystis pyrifera extract, faex extract (yeast extract), alanine, propylparaben, hydrolyzed wheat protein, pvp, carbomer, polysorbate 20, disodium succinate, palmitoyl pentapeptide-4, threonine, mourera fluviatilis extract. May contain: ci 77891(titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides).

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

PRINCIPAL DISPLAY PANEL - 30 g Carton

L'BEL

SUPRÉMACIE TEINT

replenhising foundation spf 14

30 g e (1 oz.)

Principal Display Panel - 30 g Carton
LBEL   SUPREMACIE TEINT
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate1.35 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
butylene glycol (UNII: 3XUS85K0RA)  
cyclomethicone 6 (UNII: XHK3U310BA)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
polyglyceryl-4 isostearate (UNII: 820DPX33S7)  
dimethicone (UNII: 92RU3N3Y1O)  
hexyl laurate (UNII: 4CG9F9W01Q)  
mannitol (UNII: 3OWL53L36A)  
glycerin (UNII: PDC6A3C0OX)  
glycine (UNII: TE7660XO1C)  
sodium chloride (UNII: 451W47IQ8X)  
hectorite (UNII: 08X4KI73EZ)  
propylene glycol (UNII: 6DC9Q167V3)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
sucrose (UNII: C151H8M554)  
methylparaben (UNII: A2I8C7HI9T)  
serine (UNII: 452VLY9402)  
arginine (UNII: 94ZLA3W45F)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
yeast (UNII: 3NY3SM6B8U)  
alanine (UNII: OF5P57N2ZX)  
propylparaben (UNII: Z8IX2SC1OH)  
wheat (UNII: 4J2I0SN84Y)  
polysorbate 20 (UNII: 7T1F30V5YH)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
threonine (UNII: 2ZD004190S)  
titanium dioxide (UNII: 15FIX9V2JP)  
ferric oxide red (UNII: 1K09F3G675)  
ferric oxide yellow (UNII: EX438O2MRT)  
ferrosoferric oxide (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-085-631 in 1 BOX
1NDC:14783-085-6430 g in 1 JAR
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: 8166e1da-a159-41d9-b097-3c64bbf5ad87
Set id: b6661670-0580-4859-a63f-f48798f3962a
Version: 1
Effective Time: 20100810
 
VENTURA INTERNATIONAL LTD.,