FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE VERTRA (TITANIUM DIOXIDE) STICK [EAI-JR286, INC.]

FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE VERTRA (TITANIUM DIOXIDE) STICK [EAI-JR286, INC.]
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NDC 71014-010-01, 71014-010-02
Set ID 3a2120e9-e07e-4225-bede-6736a8908d1b
Category HUMAN OTC DRUG LABEL
Packager Eai-Jr286, 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
    • Higher SPF gives more sunburn protection
    • Retains SPF after 80 minutes activity in the water, sweating, or perspiring.
    • Provides high protection against sunburn
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chilcren. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

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

  • WARNINGS

    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 leasty 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 SPF value 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.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 oxides

  • PRINCIPAL DISPLAY PANEL

    Vertra Elemental Resistance

    Foundation
    Sunscreen Face Stick
    Broad Spectrum SPF 35
    Water Resistant (80 minutes)

    Color: Cooly Beige

    11g NET WT. .39 OZ.

    cooley beige Fanning face stick SPF 35 update

    cooley beige Fanning face stick SPF 35 update stick

  • INGREDIENTS AND APPEARANCE
    FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE  VERTRA
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-010
    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)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71014-010-021 in 1 BOX10/07/2016
    1NDC:71014-010-0111 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/07/2016
    Labeler - Eai-Jr286, Inc. (827896718)
    Establishment
    NameAddressID/FEIBusiness Operations
    Toshiki Pigment Co., ltd.716140285manufacture(71014-010)

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