BALI BODY SPF 15 CACAO TANNING OIL (OCTINOXATE, OCTOCRYLENE CREAM) OIL [BALI BODY PTY LTD]

BALI BODY SPF 15 CACAO TANNING OIL (OCTINOXATE, OCTOCRYLENE CREAM) OIL [BALI BODY PTY LTD]
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NDC 70630-1805-1
Set ID 70e5fe1b-6dc6-45f5-e053-2995a90a0f59
Category HUMAN OTC DRUG LABEL
Packager Bali Body Pty Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • PRINCIPAL DISPLAY PANEL

    BB 15 4

    Octinoxate 2.8%

    Octocrylene 2.8%

    Keep out of reach of children.

    A tanning and body oil.

    Provides SPF 15 protection.

    Shake well before use. Apply liberaly 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 cool dry place.

    Vitis Vinifera (Grape) seed oil

    Cocos Nucifera Oil (Coconut)

    Olea Europaea (Olive Oil)

    Simmondsia Chinensis (Jojoba) oil

    Theobroma Cacao (Cacao)

    Vitamin E

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

    This product has been 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.

    Apply liberally 15 minutes before sun exposure.

  • INGREDIENTS AND APPEARANCE
    BALI BODY SPF 15 CACAO TANNING OIL 
    octinoxate, octocrylene cream oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-1805
    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
    JOJOBA OIL (UNII: 724GKU717M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70630-1805-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/13/201809/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/13/201809/30/2022
    Labeler - Bali Body Pty Ltd (757840223)
    Registrant - Bali Body Pty Ltd (757840223)

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