WATERMELON 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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Watermelon 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 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 2.5%,
Octinoxate 2.5%,
Avobenzone 1%.

Purpose:

Sunsreen

Inactive ingredients:

Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Hydrogenated Soy Polyglycerides, Citrullus Vulgaris (Watermelon) Seed Oil, Octocrylene, Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, Natural Watermelon Fragrance (Naturally Dervied), C15-23, BHT.

Package Labeling:

watermelon spf6

WATERMELON TANNING OIL SPF6 
octocrylene, octinoxate, avobenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0005
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)  
WATERMELON (UNII: 231473QB6R)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
C15-23 ALKANE (UNII: J3N6X3YK96)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0005-1100 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 finalpart35201/01/2021
Labeler - Bali Body Pty Ltd (757840223)

Revised: 10/2021
Document Id: cdb1442f-8d54-9a54-e053-2995a90accce
Set id: a5b2bb51-3bc4-4475-b4ae-5153451fecc8
Version: 2
Effective Time: 20211006
 
Bali Body Pty Ltd