Label: LBEL- ensulizole, octinoxate, and oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 10, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ensulizole (3 %), Octinoxate (7.5%), Oxybenzone (2 %)

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • provides moderate protection against sunburn
  • Warnings

    • For external use only.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash and irritation develops and lasts.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • moderate sun protection product.
    • apply smoothly every morning before sun exposure and as needed.
    • apply a small amount of the product to the back of clean, dry hands. Massage softly until completely absorbed.
    • children under 6 months of age: ask a doctor.
  • Other information

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Aqua (water), c12-15 alkyl benzoate, cyclopentasiloxane, saccharomyces/xylinum/black tea ferment, triethanolamine, glycerin, cyclohexasiloxane, cetyl alcohol, glyceryl stearate, cetearyl alcohol, talc, propyleneglycol, peg-100 stearate, parfum (fragance), diazolidinyl urea, phenyl trimethicone, sodium lactate, acrylates/c10-30 alkylacrilate crosspolymer, ceteareth-20, hydroxyethylcellulose, methylparaben, propylparaben, butylene glycol, hydrolyzed keratin, arctostaphylos uva ursi/leaf extract, panthenol, citrus unshiu peel extract, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, ci 77891 (titanium dioxide), tetrasodium edta, dimethiconol, phenoxyethanol, nymphaea coerulea flower extract, ci 19140 (yellow 5), ci 14700 (red 4), butylparaben, ethylparaben, isobutylparaben.

  • SPL UNCLASSIFIED SECTION

    US: Dist. by Ventura International, Ltd. San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 100 ml Carton

    L'BEL

    SUPRÉMACIE
    MAINS

    replenishing treatment
    hand cream spf 15

    100 ml e (3.3 fl.oz.)

    Principal Display Panel - 100 ml Carton
  • INGREDIENTS AND APPEARANCE
    LBEL   SUPREMACIE MAINS
    ensulizole, octinoxate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole3 g  in 100 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone6.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    tea leaf (UNII: GH42T47V24)  
    trolamine (UNII: 9O3K93S3TK)  
    glycerin (UNII: PDC6A3C0OX)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    cetyl alcohol (UNII: 936JST6JCN)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    talc (UNII: 7SEV7J4R1U)  
    propylene glycol (UNII: 6DC9Q167V3)  
    polyoxyl 100 stearate (UNII: YD01N1999R)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    sodium lactate (UNII: TU7HW0W0QT)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylene glycol (UNII: 3XUS85K0RA)  
    arctostaphylos uva-ursi leaf (UNII: 3M5V3D1X36)  
    panthenol (UNII: WV9CM0O67Z)  
    tangerine (UNII: KH3E3096OO)  
    dimethicone (UNII: 92RU3N3Y1O)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    edetate sodium (UNII: MP1J8420LU)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-072-611 in 1 BOX
    1NDC:14783-072-62100 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    LBEL   SUPREMACIE MAINS
    ensulizole, octinoxate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.15 g  in 5 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.38 g  in 5 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.31 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    tea leaf (UNII: GH42T47V24)  
    trolamine (UNII: 9O3K93S3TK)  
    glycerin (UNII: PDC6A3C0OX)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    cetyl alcohol (UNII: 936JST6JCN)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    talc (UNII: 7SEV7J4R1U)  
    propylene glycol (UNII: 6DC9Q167V3)  
    polyoxyl 100 stearate (UNII: YD01N1999R)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    sodium lactate (UNII: TU7HW0W0QT)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylene glycol (UNII: 3XUS85K0RA)  
    arctostaphylos uva-ursi leaf (UNII: 3M5V3D1X36)  
    panthenol (UNII: WV9CM0O67Z)  
    tangerine (UNII: KH3E3096OO)  
    dimethicone (UNII: 92RU3N3Y1O)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    edetate sodium (UNII: MP1J8420LU)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-062-511 in 1 BOX
    1NDC:14783-062-525 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    Labeler - VENTURA INTERNATIONAL LTD., (603192787)
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