Grape Tanning Oil SPF6 by Bali Body Pty Ltd Grape Tanning Oil SPF6

Grape Tanning Oil SPF6 by

Drug Labeling and Warnings

Grape Tanning Oil SPF6 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 70630-0016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70630-0016-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/202110/30/2021
Labeler - Bali Body Pty Ltd (757840223)

Revised: 12/2021
 

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