BALI BODY WATERMELON TANNING OIL SPF 15- avobenzone, octisalate, octocrylene oil

Bali Body Watermelon Tanning Oil SPF 15 by

Drug Labeling and Warnings

Bali Body Watermelon Tanning Oil SPF 15 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:

Sunsreen

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 sunscreen 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, Citrullus Lanatus Seed Oil, Ethylcellulose, Tocopherol, Parfum, Glycine Soja Oil, Benzyl Alcohol, Citronellol, Rose Ketone-4, Geranol, 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 15 
avobenzone, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0035
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL BENZOATE (UNII: N863NB338G)
SOYBEAN OIL (UNII: 241ATL177A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
TOCOPHEROL (UNII: R0ZB2556P8)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
WATERMELON SEED OIL (UNII: L33J06UQTT)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0035-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
2	NDC: 70630-0035-2	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2024

Labeler - Bali Body Pty Ltd (757840223)