BALI BODY PINEAPPLE TANNING OIL SPF15- octocrylene, octisalate, avobenzone oil

Bali Body Pineapple Tanning Oil SPF15 by

Drug Labeling and Warnings

Bali Body Pineapple Tanning Oil SPF15 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:

Octocrylene 9%, Octisalate 5%, Avobenzone 3%

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 ageing 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.

If product is swallowed, get medical help or contact a poison control centre right away. Please refer to balibodyco.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 suncreen 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:

• Limit time in the sun, especially from 10 a.m.-2.p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Dicaprylyl Carbonate, VP/Hexadecene Copolymer, Ethylcellulose, Sorbitan Sesquioleate, Parfum, Tocopherol, Glycerin, Ananas Sativus Fruit, Aqua, Glycine Soja Oil, Citric Acid, Sodium Benzoate, Potassium Sorbate.

Other information

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

Product Packaging

INGREDIENTS AND APPEARANCE

BALI BODY PINEAPPLE TANNING OIL SPF15 
octocrylene, octisalate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
GLYCERIN (UNII: PDC6A3C0OX)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PINEAPPLE (UNII: 2A88ZO081O)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0037-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/10/2024

Labeler - Bali Body Pty Ltd (757840223)