FDA.reportPublic FDA data

Bali Bloc SPF 30 Cocoa Sunscreen

Manufacturer
Kabana Skin Care LLC
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:43:04

Label at a glance#

ProductBali Bloc SPF 30 Cocoa Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide** USP 25%

OTC - PURPOSE SECTION

SUNSCREEN

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes, rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

INSTRUCTIONS FOR USE SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 A.M. - 2 P.M.
  • wear long-sleeve shirts, pants, hats, and sunglasses
OTC - ASK DOCTOR SECTION
  • children under 6 months: Ask a Doctor
DOSAGE & ADMINISTRATION SECTION

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

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

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bali Bloc SPF 30 Cocoa Package InsertBali Bloc SPF 30 Cocoa Package Insert

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73369-000873369-0008-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOAD9108TZ9KGIACT
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
30289310-99a6-5b92-e063-6394a90a45989640a0d1-d5a4-5ae1-e053-2a95a90aa25f2025-03-28WarningsExact identifier
spl set id: 9640a0d1-d5a4-5ae1-e053-2a95a90aa25f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.