Label: BALI BODY CACAO TANNING OIL SPF 15- octocrylene, octisalate, avobenzone oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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, 2023

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  • Drug Facts

  • Active ingredients

    Octocrylene 9%

    Octisalate 5%

    Avobenzone 3%

  • 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 ageing caused by the sun
  • 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 and ask a doctor

    if rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a poison control centre right away. Please refer to balibody.com for further sun safety instructions.

  • Directions

    Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear 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
  • Inactive ingredients

    Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Olea Europaea Fruit Oil, Theobroma Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Silica, Tocopherol, Glycine Soja Oil.

  • Other information

    • Protect this product from excessive heat and direct sun
    • Report serious adverse events to: AMS Fulfilment, 29010 Commerce Drive, Valencia CA 91355
  • Package Labeling

    cacao15

  • INGREDIENTS AND APPEARANCE
    BALI BODY CACAO TANNING OIL SPF 15 
    octocrylene, octisalate, avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-0034-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/01/2023
    Labeler - Bali Body Pty Ltd (757840223)
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