Label: BALI BODY SPF 15 PINEAPPLE TANNING OIL- octinoxate, octocrylene cream oil

  • 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 February 28, 2019

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  • ACTIVE INGREDIENT

    Octinoxate 2.8%

    Octocrylene 2.8%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    A tanning and body oil.

    Provides SPF 15 protection.

  • INDICATIONS & USAGE

    Shake well before use. Apply liberaly 15 minutes before sun exposure.

    Children under 6 months: Ask a doctor.

    Reapply every 2 hours.

    Use water-resistant sunscreen if swimming or sweating.

    Store in a cool dry place.

  • INACTIVE INGREDIENT

    • Grape seed oil;
    • Coconut oil;
    • Soybean oil;
    • Sweet almond oil;
    • Pineapple; and
    • Vitamin E.
  • WARNINGS

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

    This product has ben shown only to help prevent sunburn, not skin cancer or early skin aging.

    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.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure.

  • PRINCIPAL DISPLAY PANEL

    BB 15 3

  • INGREDIENTS AND APPEARANCE
    BALI BODY SPF 15 PINEAPPLE TANNING OIL 
    octinoxate, octocrylene cream oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-1804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.8 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.8 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-1804-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/13/2018
    Labeler - Bali Body Pty Ltd (757840223)
    Registrant - Bali Body Pty Ltd (757840223)
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