Label: SUPREMACIE- ensulizole, homosalate, octinoxate, and oxybenzone 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 7, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: ENSULIZOLE 2.0%, HOMOSALATE 2.0%, OCTINOXATE 7.0%, OXYBENZONE 4.0%.

  • WARNINGS

    WARNINGS: For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if irritation develops and lasts.

  • INDICATIONS & USAGE

    USES: Sun Protection Factor 15. Helps prevent sunburn.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Apply evenly before sun exposure and as needed.

  • PRINCIPAL DISPLAY PANEL - 50 g jar

    L'BEL
    PARIS

    SUPREMACIE NX JOUR

    traitement reconstituant crème
    de jour pour le visage fps 15
    tratamiento reconstituyente crema
    facial de día fps 15
    replenishing treatment daytime face
    cream spf 15

    peau normale à sèche / normal to dry
    skin / cutis normal a seco

    50 g e (1.7 oz.)

    PRINCIPAL DISPLAY PANEL - 50 g jar
  • INGREDIENTS AND APPEARANCE
    SUPREMACIE   NX JOUR
    ensulizole, homosalate, octinoxate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.001 g  in 5 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.001 g  in 5 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.00375 g  in 5 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.002 g  in 5 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-261-641 in 1 BOX
    1NDC:13537-261-615 g in 1 TUBE
    2NDC:13537-261-651 in 1 JAR
    2NDC:13537-261-6250 g in 1 JAR
    3NDC:13537-261-631 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/19/2010
    Labeler - Ventura Corporation, LTDA (602751344)
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