BALI BODY CACAO TANNING OIL SPF 15- octocrylene, octisalate, avobenzone 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

Drug Facts

Active ingredients

Octocrylene 9%

Octisalate 5%

Avobenzone 3%

Purpose

Sunscreen

Uses

Warnings

For external use only.

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.

Keep out of reach of children.

If product is swallowed, get medical help or contact a poison control centre right away. Please refer to balibody.com for further sun safety instructions.

Directions

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Inactive ingredients

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Olea Europaea Fruit Oil, Theobroma Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Silica, Tocopherol, Glycine Soja Oil.

Other information

Package Labeling

cacao15

BALI BODY CACAO TANNING OIL SPF 15 
octocrylene, octisalate, avobenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COCOA BUTTER (UNII: 512OYT1CRR)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0034-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/01/2023
Labeler - Bali Body Pty Ltd (757840223)

Revised: 8/2023
Document Id: 03c0cd11-ea81-10d2-e063-6394a90a21a2
Set id: 03c0b83d-0d85-9e69-e063-6394a90a6142
Version: 1
Effective Time: 20230825
 
Bali Body Pty Ltd