Label: BONDI SANDS SUNNY DAZE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 50- zinc oxide lotion

  • NDC Code(s): 79950-014-01
  • 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 25, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 25%

  • 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:
    • Every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • 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, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Polyhydroxystearic Acid, Cetearyl Alcohol, Phenoxyethanol, Polyurethane-62, Benzyl Alcohol, Saccharide Isomerate, Citric Acid, Propanediol, Lecithin, Xanthan Gum, Sodium Phytate, Ethylhexylglycerin, Trideceth-6, Tocopherol, Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Erythritol, Hibiscus Sabdariffa Fruit Extract, Iron Oxides.

  • Questions?

    888-266-0772 or visit bondisands.com

  • Company Information

    Made in Australia.

    Distributed by Bondi Sands USA

    Wilmington, DE 19808

  • Product Packaging

    bondi sands

    Everyday skincare

    Sunny

    Daze

    HYDRATING

    BROAD SPECTRUM

    SUNSCREEN SPF 50

    + HIBISCUS FRUIT EXTRACT

    Australian Made

    1.76 OZ. (50g)

    sunny daze

  • INGREDIENTS AND APPEARANCE
    BONDI SANDS SUNNY DAZE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79950-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ERYTHRITOL (UNII: RA96B954X6)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HIBISCUS SABDARIFFA WHOLE (UNII: UH3Z91Y49Y)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYURETHANE-62 (UNII: TBK645J3J8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79950-014-011 in 1 CARTON08/25/2021
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/25/2021
    Labeler - BONDI SANDS (USA) INC. (117596864)