Label: HAWAIIAN BLEND EXTREME ZINC SPF 50- zinc oxide, titanium dioxide aerosol

  • 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 January 3, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Oxide

    Titanium Dioxide

  • PURPOSE

    Zinc Oxide - 19.5% ................. Sunscreen

    Titanium Dioxide – 4.0%.................. Sunscreen

  • WARNINGS

    WARNINGS

    For external use only

    Do not use on damaged or broken skin

    when using this product keep out of eyes-rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutews befor sun exposure

    Reaaply:

    - after 80 monutes of swimming or sweating

    - immediatly after towel drying

    - at least every 2 hours

  • INDICATIONS & USAGE

    Helps prevent sunburn

    Higher SPF gives more sunburn protection

    If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

  • INACTIVE INGREDIENT

    Caprylic/Capric Triglyceride

    Caprylyl Glycol

    Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone

    Dimethicone

    Dimethicone/Methicone Copolymer

    Sodium Phytate

    Ethylhexylglycerin

    Glycerin

    Hydrogenated Polydecene

    Isopropyl Myristate

    Jojoba Esters

    Pentylene Glycol

    Polyhydroxystearic Acid

    Propanediol

    Silica

    Sodium Chloride

    Sorbitan Olivate

    Stearic Acid

    Synthetic Beeswax

    Tetrafluoropropene

    Fragrance

    Water

  • Hawaiian Blend Extreme Zinc SPF 50 Spry

    ExtremeZinc SPF 50

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN BLEND EXTREME ZINC SPF 50 
    zinc oxide, titanium dioxide aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) (UNII: KB7T6C99UP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    2,3,5,6-TETRAFLUOROPHENOL (UNII: TNA118I5TG)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-061-01142 g in 1 CAN; Type 0: Not a Combination Product01/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/03/2023
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions081030372manufacture(72667-061)
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