Bali Body Pineapple Tanning Oil SPF 6

Bali Body Pineapple Tanning Oil SPF 6

Drug Labeling and Warnings

Drug Details

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BALI BODY SPF PINEAPPLE TANNING OIL- octinoxate, octocrylene cream 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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Bali Body Pineapple Tanning Oil SPF 6

Octinoxate 2.5%

Octocrylene 2.5%

Keep out of reach of children.

A tanning and body oil.

Provides SPF 6 protection.

Shake well before use. Apply liberaly 15 minutes before sun exposure.

Children under 6 months: Ask a doctor.

Reapply every 2 hours.

Use water-resistant sunscreen if swimming or sweating.

Store in a cool dry place.

  • Grape seed oil;
  • Coconut oil;
  • Soybean oil;
  • Sweet almond oil;
  • Pineapple; and
  • Vitamin E.

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has ben shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Apply liberally 15 minutes before sun exposure.

PINEAPPLE SPF

BALI BODY SPF PINEAPPLE TANNING OIL 
octinoxate, octocrylene cream oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70630-1801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SOYBEAN OIL (UNII: 241ATL177A)  
PINEAPPLE (UNII: 2A88ZO081O)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALMOND OIL (UNII: 66YXD4DKO9)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70630-1801-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/2018
Labeler - Bali Body Pty Ltd (757840223)
Registrant - Bali Body Pty Ltd (757840223)

Revised: 8/2019
 
Bali Body Pty Ltd


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