FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD VERTRA (TITANIUM DIOXIDE) STICK [EAI-JR 286, INC]

FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD VERTRA (TITANIUM DIOXIDE) STICK [EAI-JR 286, INC]
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NDC 71014-011-01, 71014-011-02
Set ID ab1e2472-8395-4cee-ac35-8007d0d92b7d
Category HUMAN OTC DRUG LABEL
Packager Eai-jr 286, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

       Active ingredients              Purpose

    Titanium Dioxide 23%       Sunscreen

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally and evenly 15 minutes before sun exposure
    • apply to all skin exposed to sun
    • use a water resistant sunscreen if swimming or sweating
    • reapply: after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 value 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • INACTIVE INGREDIENT

    hexyldecyl isostearate, Mica, Synthetic Wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/propylene copolymer, Tocopheryl, fragrance, Iron Oxide(CI 77491), Iron Oxide(CI 77492), Iron Oxide(CI 77499)

  • PRINCIPAL DISPLAY PANEL

    Vertra Elemental Resistance

    Foundation

    Sunscreen Face Stick

    Broad Spectrum SPF 38

    Water Resistant (80 minutes)

    Color Kona Gold

    11g Net Wt. .39 oz

    Kona Gold Shane Face stick 38 art update

    Kona Gold Shane Face stick 38 stick art update

  • INGREDIENTS AND APPEARANCE
    FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD  VERTRA
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71014-011-021 in 1 BOX04/02/2018
    1NDC:71014-011-0111 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/02/2018
    Labeler - Eai-jr 286, Inc (827896718)
    Registrant - Eai-jr 286, Inc (827896718)
    Establishment
    NameAddressID/FEIBusiness Operations
    Toshiki Pigment Co., Ltd716140285manufacture(71014-011)

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