GRAPE TANNING OIL SPF6- octocrylene, octinoxate, avobenzone oil
Bali Body Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Grape Tanning Oil SPF6

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 or 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, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

Octocrylene 2.5%,
Octinoxate 2.5%,
Avobenzone 1%.

Purpose:

Sunsreen

Inactive ingredients:

Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus (Sweet Almond)Oil, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Octocrylene, Ethylhexyl Methoxycinnamate, Hydrogenated Soy Polyglyceride, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, Natural Grape Fragrance, C15-23 Alkane, BHT, Limonene, Geraniol, Linalool, Anise Alcohol.

Package Labeling:

Bottle16

GRAPE TANNING OIL SPF6
octocrylene, octinoxate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70630-0016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	25 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GRAPE SEED OIL (UNII: 930MLC8XGG)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
C15-23 ALKANE (UNII: J3N6X3YK96)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70630-0016-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021	10/30/2021

Labeler - Bali Body Pty Ltd (757840223)

Revised: 12/2021

Document Id: d28ef757-866e-64e4-e053-2995a90abf05

Set id: e26d5281-5747-468f-98e6-0cc0983194c4

Version: 2

Effective Time: 20211207

Bali Body Pty Ltd