SUPREMACIE NX JOUR- ensulizole, homosalate, octinoxate, oxybenzone, and titanium dioxide 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.

----------

Suprémacie Nx Jour Replenishing Treatment Daytime Face Cream SPF 15 Normal to Oily Skin

ACTIVE INGREDIENTS: ENSULIZOLE 1.5%, HOMOSALATE 1.0 %, OCTINOXATE 7.5%, OXYBENZONE 4.5%, TITANIUM DIOXIDE 1.17%.

INACTIVE INGREDIENTS: AQUA (WATER), CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PISUM SATIVUM (PEA) EXTRACT, CYCLOHEXASILOXANE, GLYCERIN, CETYL ALCOHOL, TRIETHANOLAMINE, PROPYLENE GLYCOL, GLYCERYL STEARATE, METHYL METHACRYLATE CROSSPOLYMER, PHENOXYETHANOL, SODIUM POLYSTYRENE SULFONATE, ERYTHRITOL, PEG-75 STEARATE, XANTHAN GUM, PARFUM (FRAGRANCE), TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, METHYLPARABEN, ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, SORGHUM BICOLOR STALK JUICE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, STEARIC ACID, PROPYLPARABEN, SILICA, SQUALANE, METHICONE, STEARETH-20, CETETH-20, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, CHLORPHENESIN, BUTYLENE GLYCOL, BUTYLPARABEN, SORBIC ACID, TETRASODIUM EDTA, ISOBUTYLPARABEN, ETHYLPARABEN, POLYSORBATE 60, HYDROLYZED ALGIN, DIMETHICONOL, CHLORELLA VULGARIS EXTRACT, MARIS AQUA (SEA WATER) , LECITHIN, CARBOMER, HOMARINE HCl, CI 19140 (YELLOW 5), BIOTINOYL TRIPEPTIDE-1, CI 14700 (RED 4).

INGREDIENTS: AQUA (WATER), ETHYLHEXYL METHOXYCINNAMATE, BENZOPHENONE-3, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, PISUM SATIVUM (PEA) EXTRACT, CYCLOHEXASILOXANE, GLYCERIN, CETYL ALCOHOL, TRIETHANOLAMINE, PHENYLBENZIMIDAZOLE SULFONIC ACID, TITANIUM DIOXIDE, PROPYLENE GLYCOL, HOMOSALATE, GLYCERYL STEARATE, METHYL METHACRYLATE CROSSPOLYMER, PHENOXYETHANOL, SODIUM POLYSTYRENE SULFONATE, ERYTHRITOL, PEG-75 STEARATE, XANTHAN GUM, PARFUM (FRAGRANCE), TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, METHYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SORGHUM BICOLOR STALK JUICE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, STEARIC ACID, PROPYLPARABEN, SILICA, SQUALANE, METHICONE, STEARETH-20, CETETH-20, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, CHLORPHENESIN, BUTYLENE GLYCOL, BUTYLPARABEN, SORBIC ACID, TETRASODIUM EDTA, ISOBUTYLPARABEN, ETHYLPARABEN, POLYSORBATE 60, HYDROLYZED ALGIN, DIMETHICONOL, CHLORELLA VULGARIS EXTRACT, MARIS AQUA (SEA WATER), LECITHIN, CARBOMER, HOMARINE HCl, CI 19140 (YELLOW 5), BIOTINOYL TRIPEPTIDE-1, CI 14700 (RED 4).

USE: Use in the morning after cleanser and toner. Apply a small quantity with your fingertips, spreading it over your face with rising, circular movements. Massage in gently to help facilitate absorption.

WARNING: For external use only. Avoid contact with eyes. Keep out of reach of children. If you observe any adverse reaction, discontinue use and consult your physician.

IMPORTANT: Provides moderate protection against sunburn.

PRINCIPAL DISPLAY PANEL - 50 mL Carton

L'BEL
PARIS

SUPRÉMACIE NX JOUR

traitement reconstituant
crème de jour pour le visage
fps 15
peau normale à grasse

replenishing treatment
daytime face cream spf 15
normal to oily skin

tratamiento reconstituyente
crema facial de día fps 15
cutis normal a graso

50 ml e (1.6 fl. oz.)

Principal Display Panel

SUPREMACIE  NX JOUR
ensulizole, homosalate, octinoxate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-093
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.00075 g  in 5 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.001 g  in 5 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.00375 g  in 5 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.00225 g  in 5 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.000585 g  in 5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-093-941 in 1 BOX
1NDC:14783-093-935 mL in 1 TUBE
2NDC:14783-093-961 in 1 BOX
2NDC:14783-093-9550 mL in 1 JAR
3NDC:14783-093-971 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/04/2010
Labeler - Ventura International LTD (603192787)

Revised: 2/2010
Document Id: 5248e1b3-7ab6-45f9-8e92-91a4432d4c5d
Set id: 5c5ac0e9-b284-4363-8a82-1e2183ef992d
Version: 1
Effective Time: 20100219
 
Ventura International LTD