BALI BODY CACAO TANNING OIL SPF15- octocrylene, octinoxate, 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 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:

cacao spf15

BALI BODY CACAO TANNING OIL SPF15 
octocrylene, octinoxate, avobenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0022-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/20/2022
Labeler - Bali Body Pty Ltd (757840223)

Revised: 2/2022
Document Id: d87aab0c-224f-1828-e053-2995a90ae35f
Set id: d87aab0c-2250-1828-e053-2995a90ae35f
Version: 1
Effective Time: 20220220
 
Bali Body Pty Ltd