BALI BODY SPF 15 CACAO TANNING OIL- octinoxate, octocrylene cream oil
Bali Body Pty Ltd

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.

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Bali Body Cacao Tanning Oil SPF 15

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.

BALI BODY SPF 15 CACAO TANNING OIL
octinoxate, octocrylene cream oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70630-1805
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
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70630-1805-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2018	09/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/13/2018	09/30/2022

Labeler - Bali Body Pty Ltd (757840223)

Registrant - Bali Body Pty Ltd (757840223)

Revised: 1/2021

Document Id: b8395f5a-40c1-53e9-e053-2995a90a041e

Set id: 70e5fe1b-6dc6-45f5-e053-2995a90a0f59

Version: 4

Effective Time: 20210106

Bali Body Pty Ltd