Label: SUPREMACIE NX JOUR- ensulizole, homosalate, octinoxate, oxybenzone, and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-093-93, 14783-093-94, 14783-093-95, 14783-093-96, view more14783-093-97 - Packager: Ventura International LTD
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 19, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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).
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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
- WARNINGS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Carton
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
SUPREMACIE NX JOUR
ensulizole, homosalate, octinoxate, oxybenzone, and titanium dioxide creamProduct 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)