Label: PETER ISLAND CONTINOUS SUNSCREEN SPF 30- octocrylene avobenzone octisalate homosalate 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 9, 2013

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  • Active ingredients

    Avobenzone 3.0%,

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 10.0%



    Purpose

    Sunscreen

  • Warnings

    For external use only

    Do not use on damaged skin or broken skin

    Stop use and ask a doctor

    if rash occurs


    When using this product

    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.

  • DIRECTIONS:


    • apply  liberally 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 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

    Sunscreen Lotion

    30

    BROAD SPECTRUM

    SPF 30

    Moisturizing

    Vitamion E and Aloe

    UVA/UVB Protection

    Water Resistant (80 minutes)

    8 FL. OZ. (236 mL)ZU0005B.jpg


  • Inactive Ingredients

    water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucoase Distearate, Diethylhexyl Syringyldenemalonate, Acrylates/C12-22 Alkyl methcrylate, Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG_100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.


  • INGREDIENTS AND APPEARANCE
    PETER ISLAND CONTINOUS SUNSCREEN  SPF 30
    octocrylene avobenzone octisalate homosalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 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
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SORBITOL (UNII: 506T60A25R)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OLETH-3 (UNII: BQZ26235UC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-711-16226 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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