BALI BODY WATERMELON TANNING OIL SPF 50- avobenzone, homosalate, octisalate, octocrylene oil

Bali Body Watermelon Tanning Oil SPF 50 by

Drug Labeling and Warnings

Bali Body Watermelon Tanning Oil SPF 50 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

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

• Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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.

In case of ingestion, get medical help or contact a poison control centre right away. Store in cool, dark place, Keep out of direct sunlight.

Directions

Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply at least every 80 minutes. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin ageing. To decrease the risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially 10am - 2 pm. Wear a long sleeve shirt, pants, hats and sunglasses. Children under 6 months of age, ask a doctor.

Inactive ingredients

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Dibutyl Adipate, Dicaprylyl Carbonate, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, VP/Hexadecene Copolymer, Ethylcellulose, Sorbitan Sesquioleate, Tocopherol, Glycerin, Parfum, Citrullus Lanatus Fruit Extract, Aqua, Glycine Soja Oil, Citric Acid.

Other information

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

Product Packaging

INGREDIENTS AND APPEARANCE

BALI BODY WATERMELON TANNING OIL SPF 50 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
WATERMELON (UNII: 231473QB6R)
WATER (UNII: 059QF0KO0R)
GRAPE SEED OIL (UNII: 930MLC8XGG)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SOYBEAN OIL (UNII: 241ATL177A)
ALMOND OIL (UNII: 66YXD4DKO9)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0036-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2025

Labeler - Bali Body Pty Ltd (757840223)