Label: BALI BODY WATERMELON TANNING OIL SPF 6- 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 21, 2023

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  • Drug Facts

  • Active ingredients

    Octisalate 5%

    Octocrylene 3%

    Avobenzone 1%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • 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 prevent sunburn, not skin cancer or early skin aging.

    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.

  • Inactive ingredients:

    Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Citrullus Lanatus Seed Oil, Tocopherol, Parfum, Glycine Soja Oil, Benzyl Alcohol, Citronellol, Rose Ketone-4, Geraniol, Linalool, Benzyl Benzoate, Benzyl Salicylate, Cinnamyl Alcohol.

  • 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

    watermelon6

  • INGREDIENTS AND APPEARANCE
    BALI BODY WATERMELON TANNING OIL SPF 6 
    octocrylene, octisalate, avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-0033-1100 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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