Label: BALI BODY PINEAPPLE TANNING OIL SPF6- 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 15 minutes before sun exposure. Children under 6 months old: Ask a doctor. Re-apply every 2 hours. Use water-resistant sunscreen if swimming or sweating. Store in a cool dry place.

  • Warnings / Cautions / Sun safety:

    Spending time in the sun increases your risk of skin cancer or early skin ageing. This product has been shown only to prevent sunburn, not skin cancer or early skin ageing.

    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. Always wear a hat, protective clothing and sunglasses.

    Keep out of reach of children.

  • Use:

    Helps prevent sunburn,

  • Active ingredients:

    Octinoxate 2.5%,
    Octocrylene 2.5%,
    Avobenzone 1.0%.

    Purpose:

    Sunsreen

  • Inactive ingredients:

    Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cocoa Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Hydrogenated Soy Polyglycerides, Octocrylene, Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ananas Sativus (Pinapple) Fruit Extract, Glycine Soja (Soybean) Oil,Tocopherol, Natural Pinapple Fragrance (Naturally Derived), C15-23 Alkane, BHT.

  • Package Labeling:

    pineapple spf6

  • INGREDIENTS AND APPEARANCE
    BALI BODY PINEAPPLE TANNING OIL SPF6 
    octocrylene, octinoxate, avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    C15-23 ALKANE (UNII: J3N6X3YK96)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-0021-1100 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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