FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD VERTRA (TITANIUM DIOXIDE) STICK [TOSHIKI PIGMENT CO., LTD]

FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38 KONA GOLD VERTRA (TITANIUM DIOXIDE) STICK [TOSHIKI PIGMENT CO., LTD]
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NDC 66990-1016-1, 66990-1016-2
Set ID d82f7c20-c7a6-4251-9959-ff11b2cd541a
Category HUMAN OTC DRUG LABEL
Packager Toshiki Pigment Co., Ltd
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

    carton

    stick

  • 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:66990-1016
    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:66990-1016-21 in 1 BOX04/02/2018
    1NDC:66990-1016-111 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 - Toshiki Pigment Co., Ltd (716140285)
    Establishment
    NameAddressID/FEIBusiness Operations
    Toshiki Pigment Co., Ltd716140285manufacture(66990-1016)

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