WAXHEAD ZINC OXIDE SUNSCREEN SPF 30- zinc oxide cream

Waxhead Zinc Oxide Sunscreen SPF 30 by

Drug Labeling and Warnings

Waxhead Zinc Oxide Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

25% non-nano Zinc Oxide (USP, uncoated)

Purpose

Sunscreen

Inactive Ingredients

Virgin Coconut Oil (cocos nucifera seed oil), Beeswax (cera alba), Vanilla Extract (vanilla planifolia extract)
(all Certified Organic by USDA/NOP)

Uses

Helps prevent sunburn. If used as directed with other sun defense
measures, decreases risk of skin cancer and aging caused by the sun

Directions

Slowly push up product from bottom of tube, then apply and spread
sunscreen in dots and stripes onto sections of face and body. (Retract
into container by tapping bottom against a hard surface.)

Reapply after 80 minutes of swimming or sweating, after towel drying,
or at least every 2 hours.

Other Sun Defense Measures
Exposure to sun increases risk of skin cancer and skin aging. To decrease
risk, regularly use sunscreen with broad spectrum SPF 30 or higher and:
limit time in the sun, especially from 10 am - 2 pm, wear long sleeve shirt,
pants, hat and sunglasses. Children under 6 months, ask a doctor.

Warnings

For external use only. Keep product out of eyes. Rinse eyes with water.
Do not use on damaged skin. Stop use and ask a doctor if rash develops.
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center immediately.

Other Info

Protect this product from excessive heat and direct sun.

Questions?

Contact Waxhead Sun Defense gowaxhead.com

Package Label

INGREDIENTS AND APPEARANCE

WAXHEAD ZINC OXIDE SUNSCREEN SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-1205
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
YELLOW WAX (UNII: 2ZA36H0S2V)	19 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L)	55.5 g  in 100 g
VANILLA (UNII: Q74T35078H)	0.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-1205-1	110 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/15/2016

Labeler - Kabana Skin Care (080237112)

Registrant - Kabana Skin Care (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(73369-1205)