Label: BONDI SANDS TOASTED COCONUT LIP BALM WITH SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene lipstick

  • NDC Code(s): 79950-002-01
  • 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 14, 2020

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  • Drug Facts

  • Active Ingredients

    Avobenzone 3%, Homosalate 8%, Octocrylene 4%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or ealy skin aging.

    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.

    Stop use and ask a doctor

    if rash or irritation develops and lasts.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least 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

    Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Synthetic Beeswax, Microcrystalline Wax/Cera Microcristallina/Cire microcrystalline, Hydrogenated Polydecene, Cetyl Palmitate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cocoglycerides, Simmondsia Chinensis (Jojoba) Seed Oil, Flavor/Aroma, Triacontanyl PVP, PEG-30 Dipolyhydroxystearate, Tocopheryl Acetate, Saccharin, Anise Alcohol.

  • 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

    LIP BALM

    with

    SPF 50

    TOASTED COCONUT

    SUNSCREEN

    LIP CARE

    Australian Made

    Net wt. 0.35 OZ. (10g)

    lip balm

  • INGREDIENTS AND APPEARANCE
    BONDI SANDS TOASTED COCONUT LIP BALM WITH SPF 50 SUNSCREEN 
    avobenzone, homosalate, octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79950-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    SACCHARIN (UNII: FST467XS7D)  
    ANISYL ALCOHOL (UNII: 7N6XGV3U49)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79950-002-011 in 1 CARTON01/01/2021
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    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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