BALI BLOC SPF 30 COCOA SUNSCREEN- zinc oxide cream 
Kabana Skin Care LLC

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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Active Ingredients

Zinc Oxide** USP 25%

Uses

Warnings

For external use only if used as directed with other sun protection measures

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

Keep out of reach of children, if product is swallowed, get medical help or contact a Poison Control Center right away

Directions

  • children under 6 months: Ask a Doctor

Inactive Ingredients

Virgin coconut oil* (Cocos nucifera seed oil), beeswax* (cera alba), cocoa powder* (Theobroma cacao seed powder)

* certified organic by USDA/NOP **non-nano, uncoated, French Process zinc oxide

Other Information

Questions or comments?

Call Kabana Skin Care toll free at 1-888-517-0414 or visit www.kabanaskincare.com

Drug Facts

Bali Bloc SPF 30 Cocoa Package Insert

BALI BLOC SPF 30 COCOA SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCOA (UNII: D9108TZ9KG) 15 g  in 100 g
YELLOW WAX (UNII: 2ZA36H0S2V) 15 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L) 45 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73369-0008-1110 g in 1 TUBE; Type 0: Not a Combination Product10/08/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/08/2014
Labeler - Kabana Skin Care LLC (080237112)
Registrant - Kabana Skin Care LLC (080237112)
Establishment
NameAddressID/FEIBusiness Operations
Kabana Skin Care LLC080237112manufacture(73369-0008)

Revised: 10/2023
Document Id: 06c47318-c430-e56e-e063-6394a90a086f
Set id: 9640a0d1-d5a4-5ae1-e053-2a95a90aa25f
Version: 5
Effective Time: 20231002
 
Kabana Skin Care LLC