BADGER SPF 15 SUNSCREEN LIP BALM- zinc oxide stick

Badger SPF 15 Sunscreen Lip Balm by

Drug Labeling and Warnings

Badger SPF 15 Sunscreen Lip Balm 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 8%

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 swallowed, get medical help or contact a poison control center right away.

Directions

• For full protection, apply liberally (2mg/cm 2 of skin) to lips, then rub in to reduce whitening effect
• Use a water resistant sunscreen if swimming or sweating

Reapply:

• 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 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

1Olea Europaea ( Extra Virgin Olive) Oil, 1Cera Alba ( Beeswax), 1Theobroma Cacao ( Cocoa) Butter, 1Butyrospermum Parkii ( Shea) Butter, Tocopherol ( Sunflower Vitamin E).

1 = Certified Organic

PRINCIPAL DISPLAY PANEL

BADGER ®

Unscented

Broad Spectrum SPF 15

SUNSCREEN LIP BALM

Net Wt 4.2g/.15 oz

98% Organic Ingredients

INGREDIENTS AND APPEARANCE

BADGER SPF 15 SUNSCREEN LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62206-4654
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62206-4654-1	1 in 1 BOX	07/16/2018
1		4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
W.S. BADGER COMPANY, INC.		963242326	manufacture(62206-4654)