Label: PETER ISLAND 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%
    Octocrylene 10.0%
    Oxybenzone 6.0%
    Octisalate 5.0%
    Avobenzone 3.0%

  • Warning

    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 vitamin enriched formula is very water resistant, fragrance free, PABA free and provides Broad Spectrum UVA/UVB protection.
  • Principal Display Panel

    PETER ISLAND
    Sunscreen lotion
    spf 70
    Photostable
    Broad Spectrum
    UVA/UVB Protection
    Very Water Resistant
    8 FL.OZ. (237 mL)
    ZU0004A0F.jpg
    ZU0004A0b.jpg


  • Inactive Ingredients

    Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.
  • INGREDIENTS AND APPEARANCE
    PETER ISLAND SUNSCREEN  SPF 70
    homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50390-704
    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) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50390-704-56226 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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