Label: PETER ISLAND NATURAL MINERALSPF 60 SPF 60- titanium dioxide zinc oxide lotion

  • 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 July 8, 2013

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  • Active ingredients

    Titanium Dioxide 2.8%

    Zinc Oxide 4.0%


    Purpose

    Sunscreen

  • Warnings

    For external use only.
    Do not use on damaged skin or broken skin. Rinse with water to remove


    When using this product keep out of eyes.


    stop use and ask a doctor if rash occurs


    Keep out of reach of children.


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

    May stain some fabrics.

  • DIRECTIONS:

    • apply literally 15 minutes before sun exposure
    • 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 increase your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:


    • Limit time in the sun, especially from 10 am - 2 pm
    • Wear long sleeves shirts, pants, hats and sunglasses
    • children under 6 month of age: Ask a doctor

  • OTHER INFORMATION:

    protect this product from excessive heat and direct sun


  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions).
    • decrease the risk of skin cancer and early skin caused by the sun.
  • Principal Display Panel

    PETER

    ISLAND

    NATURAL MINERAL

    SUNSCREEN LOTION

    100%

    Naturally

    Sourced

    Sunscreen

    Ingredients

    with Zinc Oxide and Titanium Dioxide

    BROAD SPECTRUM

    SPF 60

    Dermatologist Tested

    UVA/UVB Protection

    Water Resistant (80 Minutes)

    4 Fl. OZ. (118 mL)

    ZU0011A0.jpg
  • INACTIVE INGREDIENTS:

    Water, Caprylic Capric Triglyceride, Butyloctyl Salicylate, Phenethyl Benxoate, Cetyl PEG/PPG-10/1 Dimethicone, Laurly PEG-8 Dimethicone, Ozokerite, Cyclopentasiloxane, Cyclohexasiloxane , C30-38 Olefin/Isopropyl Maleate MA Copolymer, Ethylhexyl Methocrylene, PEG-8, Sodium Chloride, Caprylyl Glycol, Dimethicone, Alumina, Methicone, Glycerin, Sodium Citrate, Disodium EDTA, Panthenol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol.


  • INGREDIENTS AND APPEARANCE
    PETER ISLAND NATURAL MINERALSPF 60   SPF 60
    titanium dioxide zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-708-23118 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/08/2013
    Labeler - Access Business Group LLC (839830713)
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