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

Supremacie by

Drug Labeling and Warnings

Supremacie by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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).

SPL UNCLASSIFIED SECTION

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).

INDICATIONS & USAGE

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.

WARNINGS

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.

SPL UNCLASSIFIED SECTION

IMPORTANT: Provides moderate protection against sunburn.

• HYPOALLERGENIC.
• DERMATOLOGICALLY AND CLINICALLY TESTED.

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.)

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

SUPREMACIE  NX JOUR
ensulizole, homosalate, octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-093
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.00075 g  in 5 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.001 g  in 5 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.00375 g  in 5 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.00225 g  in 5 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.000585 g  in 5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-093-94	1 in 1 BOX
1	NDC: 14783-093-93	5 mL in 1 TUBE
2	NDC: 14783-093-96	1 in 1 BOX
2	NDC: 14783-093-95	50 mL in 1 JAR
3	NDC: 14783-093-97	1 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/04/2010

Labeler - Ventura International LTD (603192787)