WAXHEAD TINTED ZINC OXIDE SUNSCREEN SPF 30- zinc oxide cream 
Kabana Skin Care

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.

----------

Active Ingredients

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

Inactive Ingredients

Virgin Coconut Oil (cocos nucifera seed oil), Beeswax (cera alba), Cocoa powder (theobroma cacao seed powder)
(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

Waxhead Tinted SPF 30 Label

WAXHEAD TINTED ZINC OXIDE SUNSCREEN SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-1206
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
COCONUT OIL (UNII: Q9L0O73W7L) 45 g  in 100 g
YELLOW WAX (UNII: 2ZA36H0S2V) 15 g  in 100 g
COCOA (UNII: D9108TZ9KG) 15 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73369-1206-1110 g in 1 TUBE; Type 0: Not a Combination Product04/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2016
Labeler - Kabana Skin Care (080237112)
Registrant - Kabana Skin Care (080237112)
Establishment
NameAddressID/FEIBusiness Operations
Kabana Skin Care080237112manufacture(73369-1206)

Revised: 10/2023
Document Id: 06c4cc42-a217-3949-e063-6394a90a665e
Set id: b8d5274c-a46d-7fe6-e053-2a95a90a06e3
Version: 4
Effective Time: 20231002
 
Kabana Skin Care