Label: ESIKA- ensulizole, octinoxate, octisalate, octocrylene, 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 May 27, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ensulizole (3%), Octinoxate (7.5%), Octisalate (5%), Octocrylene (7%), Oxybenzone (6%),Titanium Dioxide (4.68%)

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
  • 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

    • Apply smoothly every morning before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
  • Other information

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

    Aqua (water), dicaprylyl carbonate, vp/eicosene copolymer, phenethyl benzoate, arginine, cyclohexasiloxane, cetearyl alcohol, sorbitan stearate, dimethicone, glyceryl stearate, potassium cetyl phosphate, phenoxyethanol, trimethylsiloxysilicate, silica, disodium lauriminodipropionate tocopheryl phosphates, methyl methacrylate crosspolymer, methicone, methylparaben, ceteareth-20, propylparaben, xanthan gum, parfum (fragrance), cyclopentasiloxane, butylparaben, ethylparaben, isobutylparaben.

  • PRINCIPAL DISPLAY PANEL - 82 g Bottle Label

    UVB SPF
    50
    High Protection
    UVA

    Perfect
    sun
    kids

    protector against solar
    rays for children, face and
    body SPF 50

    ēsika

    80 g e (2.8 oz.)

    PRINCIPAL DISPLAY PANEL - 82 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA   PERFECT SUN KIDS
    ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.03 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.07 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.6 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.0468 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    ARGININE (UNII: 94ZLA3W45F)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-363-0180 g in 1 BOTTLE
    2NDC:13537-363-021 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/30/2011
    Labeler - Ventura Corporation (San Juan, P.R) (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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