BALI BODY WATERMELON TANNING OIL SPF 6- octocrylene, octisalate, avobenzone oil

Bali Body Watermelon Tanning Oil SPF 6 by

Drug Labeling and Warnings

Bali Body Watermelon Tanning Oil SPF 6 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octisalate 5%

Octocrylene 3%

Avobenzone 1%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

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

• Protect this product from excessive heat and direct sun
• Report serious adverse events to: AMS Fulfilment, 29010 Commerce Drive, Valencia CA 91355

Package Labeling

INGREDIENTS AND APPEARANCE

BALI BODY WATERMELON TANNING OIL SPF 6 
octocrylene, octisalate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0033
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL BENZOATE (UNII: N863NB338G)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
WATERMELON SEED OIL (UNII: L33J06UQTT)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL ALCOHOL (UNII: LKG8494WBH)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
GERANIOL (UNII: L837108USY)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0033-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2023

Labeler - Bali Body Pty Ltd (757840223)