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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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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  • 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.)

    Principal Display Panel
  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    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)
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