Product Information / Drug Facts

Directions:

Shake well before use. Apply liberally 15 minutes before sun exposure. Children under 6 months old: Ask a doctor. Re-apply every 2 hours. Use water-resistant sunscreen if swimming or sweating. Store in a cool dry place.

Warnings / Cautions / Sun safety:

Spending time in the sun increases your risk of skin cancer and early skin ageing. This product has been shown only to prevent sunburn, not skin cancer or early skin ageing.

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. Always wear a hat, protective clothing and sunglasses.

Keep out of reach of children.

Use:

Helps prevent sunburn,

Active ingredients:

Octocrylene 1.0%,

Octinoxate 1.0%,

Avobenzone 0.5%.

Purpose:

Sunsreen

Inactive ingredients:

Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Butter, Dicaprylyl Carbonate, Hydrogenated Soy Polyglycerides, Octocrylene, Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, C15-23 Alkane, BHT.

Package Labeling:

cacao spf6

BALI BODY CACAO TANNING OIL SPF6
octocrylene, octinoxate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70630-0023
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCOA (UNII: D9108TZ9KG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
C15-23 ALKANE (UNII: J3N6X3YK96)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70630-0023-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/20/2022

Labeler - Bali Body Pty Ltd (757840223)

Bali Body Cacao Tanning Oil SPF6