BALI BODY SPF CACAO TANNING OIL- octinoxate, octocrylene cream oil

Bali Body SPF Cacao Tanning Oil by

Drug Labeling and Warnings

Bali Body SPF Cacao Tanning Oil by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd, Natural Beauty Care Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Octinoxate 2.5%

Octocrylene 2.5%

Keep out of reach of children.

A tanning and body oil.

Provides SPF 6 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 CACAO TANNING OIL 
octinoxate, octocrylene cream oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-1602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-1602-1	110 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/11/2016

Labeler - Bali Body Pty Ltd (757840223)

Registrant - Bali Body Pty Ltd (757840223)

Establishment
Name	Address	ID/FEI	Business Operations
Bali Body Pty Ltd		757840223	manufacture(70630-1602)