Label: ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50- ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide lotion

  • 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 December 17, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Ensulizole (3%)Sunscreen
    Octinoxate (7.5%)Sunscreen
    Octisalate (5%)Sunscreen
    Octocrylene (7%)Sunscreen
    Oxybenzone (6%)Sunscreen
    Titanium Dioxide (4.7%)Sunscreen
  • Uses

    • Helps prevent sunburn
  • Warnings

    • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

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

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label

    SPF
    50

    Perfect
    sun
    Kids

    Sunscreen

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

    ēsika

    80 ml e (2.7 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA   PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50
    ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.03 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.07 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.046 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARGININE (UNII: 94ZLA3W45F)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-224-0180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/16/2013
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-224)
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