Bali Body Cacao Tanning Oil SPF15

Bali Body Cacao Tanning Oil SPF15 by

Drug Labeling and Warnings

Bali Body Cacao Tanning Oil SPF15 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 CACAO TANNING OIL SPF15- octocrylene, octinoxate, avobenzone oil 
Bali Body Pty Ltd

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Bali Body Cacao Tanning Oil SPF15

Product Information / Drug Facts

Directions:

Shake well before use. Apply liberally 20 minutes before sun exposure. Re-apply your BB every 1-2 hours, after swimming or exercise..

Warnings / Cautions / Sun safety:

When using this product

keep out of eyes. If contact occurs rinse with water to remove. 

Stop use and seek medical advise

if rash occurs. Wear sun-smart options such as hat and sunglasses.

Do not use

on damaged or broken skin. Can aid in the prevention of premature skin ageing.

Keep out of reach of children.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

Octocrylene 3.0%,

Octinoxate 2.0%,

Avobenzone 1.5%.

Purpose:

Sunsreen

Inactive ingredients:

Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Powder, Dicaprylyl Carbonate, Octocrylene, Ethylhexyl Methoxycinnamate, Hydrogenated Soy Polyglyceride, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, BHT, C15-23 Alkane.

Package Labeling:

BALI BODY CACAO TANNING OIL SPF15 
octocrylene, octinoxate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCOA (UNII: D9108TZ9KG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
C15-23 ALKANE (UNII: J3N6X3YK96)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0022-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/20/2022	10/22/2024

Labeler - Bali Body Pty Ltd (757840223)

Revised: 10/2024

Document Id: 25117ef4-9dee-7507-e063-6394a90a502a

34390-5

Set id: d87aab0c-2250-1828-e053-2995a90ae35f

Version: 2

Effective Time: 20241022