WAXHEAD BABY SUNSCREEN SPF 35- sunscreen 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.

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Active Ingredients

25% Non-Nano Zinc Oxide (Uncoated, French Process)

Purpose

Sunscreen

Inactive Ingredients

Spring water (aqua), Extra virgin olive oil* (oleo europaea fruit oil), Beeswax* (cera alba), Non-GMO Vegetable Vitamin E (tocopherol), Vitamin D3 (cholecalciferol). *Certified Organic by USDA/NOP

Uses

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

Warnings

For external use only. Keep product out of eyes. Rinse with water to
remove. 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.

Directions

​Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of
swimming or sweating, immediately after towel drying, or every 2 hours.


Sun Protection Measures. Exposure to sun increases risk of skin cancer
and skin aging. To decrease risk, regularly use sunscreen with broad
spectrum SPF 15 or higher and other sun defense measures including:
limit time in the sun, especially from 10 AM to 2 PM, wear long sleeve
shirts, pants, hats and sunglasses. Children under 6 months, ask a doctor.

Other Information

Keep this product away excessive heat and direct sun. Shake before use.

Questions?

Contact Waxhead Sun Defense gowaxhead.com.

Package Label

Waxhead Baby SPF 30

WAXHEAD BABY SUNSCREEN SPF 35 
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-1204
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
YELLOW WAX (UNII: 2ZA36H0S2V) 4.75 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 1.25 g  in 100 g
WATER (UNII: 059QF0KO0R) 2 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E) 67 g  in 100 g
CHOLECALCIFEROL (UNII: 1C6V77QF41) 0.000000335 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73369-1204-1115 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(73369-1204)

Revised: 10/2023
Document Id: 06c4ab0b-2037-c8fa-e063-6294a90a73af
Set id: b830b4a0-afa6-df37-e053-2a95a90a614c
Version: 4
Effective Time: 20231002
 
Kabana Skin Care