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

BALI BODY SPF TANNING AND BODY OIL (OCTINOXATE, OCTOCRYLENE CREAM) OIL [BALI BODY PTY LTD]
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NDC	70630-1802-1
Set ID	70e58a6f-c3e5-5648-e053-2a95a90a4962
Category	HUMAN OTC DRUG LABEL
Packager	Bali Body Pty Ltd
Generic Name
Product Class
Product Number
Application Number	PART352

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PRINCIPAL DISPLAY PANEL

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

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 TANNING AND BODY OIL SPF 15
octinoxate, octocrylene cream oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70630-1802
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.8 mg in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
OLIVE OIL (UNII: 6UYK2W1W1E)
GRAPE SEED OIL (UNII: 930MLC8XGG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70630-1802-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2018	03/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/13/2018	03/31/2023

Labeler - Bali Body Pty Ltd (757840223)

Registrant - Bali Body Pty Ltd (757840223)

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