Label: BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 79950-011-01
  • Packager: BONDI SANDS (USA) INC.
  • 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 August 5, 2021

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  • Drug Facts

  • Active Ingredients

    Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use

    on damaged or broken skin.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs.

  • 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 increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
    • You may report a serious adverse reaction to 888-266-0772; Monday – Friday, 9 am – 5 pm.
  • Inactive Ingredients

    Water, Beeswax, C12-15 Alkyl Benzoate, Silica, PEG-15 Cocamine, Caprylyl Glycol, PEG-40 Stearate, Acrylates/Steareth-20 Methacrylate Copolymer, Caprylhydroxamic Acid, Glycerin, Carbomer, Sodium Hydroxide, Phenoxyethanol, Sodium Carrageenan, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Sodium Chloride.

  • Questions?

    888-266-0772 or visit bondisands.com

  • Company Information

    Made in Australia.

    Distributed by Bondi Sands USA

    Wilmington, DE 19808

    bondisands.com

  • Product Packaging

    bondi sands

    The Australian tan

    BROAD SPECTRUM

    HYDRA

    UV PROTECT

    SPF 70

    SUNSCREEN SPRAY

    VERY WATER RESISTANT 80 MINUTES

    PLANT BASED HYDRATION

    REEF FRIENDLY

    Australian Made

    5.07 FL. OZ. (150mL)

    hydra spray

  • INGREDIENTS AND APPEARANCE
    BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79950-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79950-011-01150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/05/2021
    Labeler - BONDI SANDS (USA) INC. (117596864)
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