Label: PREMIUM ULTRA UV PURE SUN- octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stick

  • 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 August 8, 2017

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  • ACTIVE INGREDIENT

    Octocrylene, Ethylhexyl Methoxycinnamate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ethylhexyl Salicylate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, etc.

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skn that will be exposed to ultraviolet sunlight.

  • WARNINGS

    Do not use on damaged or broken skin.

    When using this product
    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use if following symptoms occur. (Continuing in usage may increase symptoms, ask doctor.)

    1) If any red spots, swelling, itching, or skin irritation develops.

    2) If direct sunlight causes irritation

    Keep out of reach of children
    • Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control

    Center right away.

    Store at room temperature
    • Close lid after use – possibility of contamination may exists if displaced contents are replaced back to container.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PREMIUM ULTRA UV PURE SUN 
    octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71609-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE7 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71609-0009-115 g in 1 CONTAINER; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Labeler - Purecell Korea Co., Ltd. (694667185)
    Registrant - Purecell Korea Co., Ltd. (694667185)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purecell Korea Co., Ltd.557799448label(71609-0009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71609-0009)
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