BALI BODY WATERMELON TANNING OIL SPF 6- 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 Watermelon Tanning Oil SPF6

Drug Facts

Active ingredients

Octisalate 5%

Octocrylene 3%

Avobenzone 1%

Purpose

Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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.

Inactive ingredients:

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Citrullus Lanatus Seed Oil, Tocopherol, Parfum, Glycine Soja Oil, Benzyl Alcohol, Citronellol, Rose Ketone-4, Geraniol, Linalool, Benzyl Benzoate, Benzyl Salicylate, Cinnamyl Alcohol.

Other information

Package Labeling

watermelon6

BALI BODY WATERMELON TANNING OIL SPF 6 
octocrylene, octisalate, avobenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BENZYL BENZOATE (UNII: N863NB338G)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
ALMOND OIL (UNII: 66YXD4DKO9)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
WATERMELON SEED OIL (UNII: L33J06UQTT)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0033-1100 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: 0370297f-845f-6803-e063-6294a90ae7d7
Set id: 03705641-feaf-2cbd-e063-6394a90a806e
Version: 1
Effective Time: 20230821
 
Bali Body Pty Ltd