Label: PETER ISLAND ULTIMATE SHEER DRY TOUCH SUNSCREEN SPF 70- homosalate, oxybenzone, octisalate, avobenzone, octocrylene 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 November 26, 2012

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  • Active Ingredients

    Homosalate 15.0%
    Oxybenzone 6.0%
    Octisalate 5.0%
    Avobenzone 3.0%
    Octocrylene 2.8%


  • WARNINGS:

    FOR EXTERNAL USE ONLY.
    Avoid contact with eyes. Rinse with water if contact occurs.

    Discontinue use if signs of rash or irritation develop.

    For use on children under the age of 6 months consult a physician.

    Keep out of reach of children.
  • Directions

    Apply generously and evenly 30 minutes before sun exposure. Reapply frequently and after swimming, excessive perspiration and towel drying.
  • Other Information

    • May stain some fabrics
    • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • SPL UNCLASSIFIED SECTION

    This Sheer Dry-Touch Sunscreen provides Broad Spectrum UVA/UVB protection from the sun's damaging rays. It's PABA free,oil-free and non-greasy. This light weight formula is dermatologist tested, offers a light fresh scent and is very water resistant.
  • Principal Display Panel

    PETER ISLAND
    ULTIMATE SHEER
    DRY-TOUCH SUNSCREEN
    Oil Free Light, Clean Feel
    spf 70
    Photostable
    Broad Spectrum
    UVA/UVB Protection
    DERMATOLOGIST TESTED
    Very Water Resistant
    3 FL.OZ. (89 mL)
    ZU0007A0.jpg




  • Inactive Ingredients

    Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, Silica, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Methicone, Sodium Polyacrylate, Benzyl Alcohol, Beeswax, Ethylhexyl Stearate, Dimethicone, Cetyl Dimethicone, Xanthan Gum, Trimethylsiloxysilicate, Trideceth-6, Disodium EDTA, Dipotassium Glycyrrhizate, BHT, Chlorphenesin
  • INGREDIENTS AND APPEARANCE
    PETER ISLAND ULTIMATE SHEER DRY TOUCH SUNSCREEN  SPF 70
    homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50390-707
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 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
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TETRASILANE (UNII: OI9DXJ0BL4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50390-707-1285 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/26/2012
    Labeler - AMWAY CORP. (083416854)
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