Label: ESIKA PERFECT SUN- avobenzone, octisalate, octocrylene, and oxybenzone liquid

  • 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 January 26, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    AVOBENZONE (3.0%)Sunscreen
    OCTISALATE (5.0%)Sunscreen
    OCTOCRYLENE (10.0%)Sunscreen
    OXYBENZONE:6.0%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    • 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:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.–2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information

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

    ALCOHOL DENAT., CYCLOPENTASILOXANE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, C12-15 ALKYL BENZOATE, DIMETHICONE, FRAGRANCE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE.

  • SPL UNCLASSIFIED SECTION

    P.R.: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

  • PRINCIPAL DISPLAY PANEL - 150 ml Bottle

    SPF
    30
    BROAD
    SPECTRUM

    Perfect
    sun

    sunscreen body spray SPF 30
    WATER RESISTANT
    (40 MINUTES)

    ēsika

    150 ml e (5 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 150 ml Bottle
  • INGREDIENTS AND APPEARANCE
    ESIKA   PERFECT SUN
    avobenzone, octisalate, octocrylene, and oxybenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    dimethicone (UNII: 92RU3N3Y1O)  
    alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-153-01150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/24/2012
    Labeler - Ventura Corporation, Ltd. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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