BADGER UNSCENTED SPF 28 SUNSCREEN- zinc oxide cream

Badger Unscented SPF 28 Sunscreen by

Drug Labeling and Warnings

Badger Unscented SPF 28 Sunscreen by is a Otc medication manufactured, distributed, or labeled by W.S. Badger Company, Inc., W.S. BADGER COMPANY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Non-Nano Uncoated Zinc Oxide 18.75%

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

Do not use on damaged or broken skin. Stop and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

• For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.

Reapply:

• After 40 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am-2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses
• For children under 6 months of age: ask a doctor.

Ingredients

*Helianthus Annuus ( Sunflower) Oil, *Cera Alba (Beeswax), Tocopherol (Sunflower Vitamin E), *Hippophae Rhamnoides (Seabuckthorn) Fruit Extract.

* = Certified Organic

Other Information

Protect the product in this container from excessive heat and direct sunlight.

PRINCIPAL DISPLAY PANEL - 87 ml Tube Label

Active
BADGER ®

Unscented

Broad Spectrum

SPF 28

NATURAL MINERAL

SUNSCREEN CREAM

Safe Effective Family Friendly

WATER RESISTANT 40min

NON GMO

NON NANO

BIO DEGRADABLE

NATURAL PRODUCTS ASSOCIATION

83% ORGANIC INGREDIENTS

NSF

87ml/2.9 fl.oz

INGREDIENTS AND APPEARANCE

BADGER UNSCENTED SPF 28 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62206-4739
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62206-4739-0	87 mL in 1 TUBE; Type 0: Not a Combination Product	07/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/16/2018

Labeler - W.S. Badger Company, Inc. (963242326)

Establishment
Name	Address	ID/FEI	Business Operations
W.S. BADGER COMPANY, INC.		963242326	manufacture(62206-4739)