Bali Body Grape Tanning Oil SPF 6

Bali Body SPF 15 Cacao Tanning Oil by

Drug Labeling and Warnings

Bali Body SPF 15 Cacao Tanning Oil by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Grape Tanning Oil SPF 6

Octinoxate 2.5%

Octocrylene 2.5%

Avobenzone 1%

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)

Sweet Almond Oil

Vitamin E

Dicaprylyl Carbonate

Hydrogenated Soy Polyglycerides

Soybean Oil

C15-23 Alkane

BHT

Limonene

Geraniol

Linalool

Anise Alcohol

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: 70630-1901
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
C15-23 ALKANE (UNII: J3N6X3YK96)
COCONUT OIL (UNII: Q9L0O73W7L)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SOYBEAN OIL (UNII: 241ATL177A)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-1901-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/17/2019	08/08/2019

Labeler - Bali Body Pty Ltd (757840223)

Registrant - Bali Body Pty Ltd (757840223)

Revised: 8/2019

Document Id: 8fa0cafc-08b4-8755-e053-2995a90aeec0

34390-5

Set id: 8b88a95f-170c-34bf-e053-2995a90adcf3

Version: 2

Effective Time: 20190808

 

Bali Body Pty Ltd