BALI BLOC SPF 30 VANILLA SUNSCREEN- zinc oxide cream

Bali Bloc SPF 30 Vanilla Sunscreen by

Drug Labeling and Warnings

Bali Bloc SPF 30 Vanilla Sunscreen by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide** USP 25%

Purpose

Sunscreen

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

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

• 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

• children under 6 months: Ask a Doctor

Inactive Ingredients

Virgin coconut oil* (Cocos nucifera seed oil), beeswax* (cera alba), vanilla extract* (aqua (and) ethanol (and) Vanilla planifolia extract)

*Certified Organic by USDA/NOP **non-nano, uncoated, French Process zinc oxide

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

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

Drug Facts

INGREDIENTS AND APPEARANCE

BALI BLOC SPF 30 VANILLA SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VANILLA (UNII: Q74T35078H)	0.5 g  in 100 g
YELLOW WAX (UNII: 2ZA36H0S2V)	19 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L)	55.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-0007-1	110 g in 1 TUBE; Type 0: Not a Combination Product	12/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/28/2015

Labeler - Kabana Skin Care LLC (080237112)

Registrant - Kabana Skin Care LLC (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care LLC		080237112	manufacture(73369-0007)