Label: CLEAR FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 45- titanium dioxide, zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

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 March 12, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Titanium Dioxide 14% Sunscreen

    Zinc Oxide 6% Sunscreen

  • PURPOSE

    • 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 children:

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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 and and at least every 2 hours
    reapply: after 80 minutes of swimming or sweating

    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 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
    immediately after towel drying

  • INDICATIONS & USAGE

    Stop use and ask a doctor if:

    rash or irritation develops and lasts

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Dimethicone, Caprylic/Capric Triglyceride, Alumina, Lecithin, Stearic Acid, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Squalane, Paraffin, Ceresin, Isononoyl Isononanoate, Microcrystalline Wax, Glycerin, Isopentyldiol, Polyethylene, HDI/Trimethylol Hexyllactone Crosspolymer, Polyglyceryl-6 Polyricinoleate, PEG-10 Dimethicone, Phenxoyethanol, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Triethoxycaprylylsilane, Disodium EDTA, Silica, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    Vertra Elemental Resistance

    Foundation Sunscreen Face Stick

    Broad Spectrum SPF 45

    Water Resistant (80 Minutes)

    Color: Clear

    11g NET WT. 0.39

    Invisible stick updated art

    Invisible stick updated art primary

  • INGREDIENTS AND APPEARANCE
    CLEAR FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 45 
    titanium dioxide, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71014-012-0111 g in 1 BOX; Type 0: Not a Combination Product04/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/15/2018
    Labeler - Eai-jr 286, Inc (827896718)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwest Cosmetic Laboratories LLC929572014manufacture(71014-012)
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