Label: BALI BODY CACAO TANNING OIL SPF15- octocrylene, octinoxate, 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 February 20, 2022

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  • Product Information / Drug Facts

  • Directions:

    Shake well before use. Apply liberally 20 minutes before sun exposure. Re-apply your BB every 1-2 hours, after swimming or exercise..

  • Warnings / Cautions / Sun safety:

    When using this product

    keep out of eyes. If contact occurs rinse with water to remove. 

    Stop use and seek medical advise

    if rash occurs. Wear sun-smart options such as hat and sunglasses.

    Do not use

    on damaged or broken skin. Can aid in the prevention of premature skin ageing.

    Keep out of reach of children.

  • Use:

    Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

  • Active ingredients:

    Octocrylene 3.0%,

    Octinoxate 2.0%,

    Avobenzone 1.5%.

    Purpose:

    Sunsreen

  • Inactive ingredients:

    Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Powder, Dicaprylyl Carbonate, Octocrylene, Ethylhexyl Methoxycinnamate, Hydrogenated Soy Polyglyceride, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, BHT, C15-23 Alkane.

  • Package Labeling:

    cacao spf15

  • INGREDIENTS AND APPEARANCE
    BALI BODY CACAO TANNING OIL SPF15 
    octocrylene, octinoxate, avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCOA (UNII: D9108TZ9KG)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    C15-23 ALKANE (UNII: J3N6X3YK96)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-0022-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/20/2022
    Labeler - Bali Body Pty Ltd (757840223)
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