Label: PETER ISLAND CONTINOUS SUNSCREEN KIDS SPF 50- oxybenzone, avobenzone, octocrylene spray

  • 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 9, 2013

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  • Active ingredients

    Avobenzone 3.0%, Octocrylene 10.0%, Oxybenzone 5.0%



    Purpose

    Sunscreen

  • Warnings

    For external use only
    Flammable: Do not Puncture or incinerate, Contents under pressure.

    Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark. Keep away from sources of Ignition-No smoking.


    Stop use and ask a doctor

    if rash occurs


    When using this product

    • Keep away from face to avoid breaching it
    • keep out of eyes
    • Rinse with water to remove.


    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.
    • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • DIRECTIONS:

    • hold container 4-6 inches from the skin to apply
    • spray liberally and spread evenlyb by hand 15 minutes before sun exposure
    • Do not spray directly on face.
    • Spray on hands then apply to face
    • do not apply in windy conditionss
    • use in well-ventiliated area
    • 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 a.m.- 2 p.m
    • wear long -sleeve shirts, pants, hats and sunglasses
    • children under 6 months 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 aging caused by the sun.

  • Principal Display Panel

    PETER

    ISLAND

    Continous Spray Sunscreen

    Kids 50

    BROAD SPECTRUM

    SPF 50

    Won't Run Into Eyes

    UVA/UVB Protection

    Water Resistant(80 minutes)

    6 FL.OZ. (177 mL)

    ZU0010A0.jpg
  • Inactive Ingredients:

    Alcohol decant, Acrylates/octylacrylamide Copolymer, Caprylyl Glycol, Mineral Oil, PEG_8 Dimethicone, Aloe Barbadensis Leaf Extract, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Leaf Extract, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Fragrance.


  • INGREDIENTS AND APPEARANCE
    PETER ISLAND CONTINOUS SUNSCREEN KIDS  SPF 50
    oxybenzone, avobenzone, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-710-34177 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/09/2013
    Labeler - Access Business Group LLC (839830713)
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