Label: BONDI SANDS FRAGRANCE FREE FACE SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 79950-006-01
  • Packager: BONDI SANDS (USA) INC.
  • Category: HUMAN OTC DRUG LABEL

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 14, 2020

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  • Drug Facts

  • Active Ingredients

    Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 8%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protections measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.
    • Retains SPF after 80 minutes of activity in the water.
  • 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 or irritation develops and lasts.

  • 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/Aqua/Eau, Beeswax/Cera Alba/Cire d'abeille, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Saccharide Isomerate, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Sodium Chloride, Citric Acid.

  • Questions?

    888-266-0772 or visit bondisands.com

  • Company Information

    Made in Australia.

    Distributed by Bondi Sands USA

    Wilmingon, 19808, DE.

    bondisands.com

  • Product Packaging

    bondi sands

    The Australian tan

    DAILY MOISTURIZING

    FACE

    SPF 50

    BROAD SPECTRUM

    VERY WATER RESISTANT 80 MINUTES

    FRAGRANCE FREE

    SUNSCREEN LOTION

    REEF FRIENDLY

    72HR HYDRATION

    SUITABLE FOR SENSITIVE SKIN

    Australian Made

    2.53 FL. OZ. (75mL)

    face spf50

  • INGREDIENTS AND APPEARANCE
    BONDI SANDS FRAGRANCE FREE FACE SPF 50 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79950-006
    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) OCTOCRYLENE80 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79950-006-0175 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2021
    Labeler - BONDI SANDS (USA) INC. (117596864)
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