BADGER BROAD SPECTRUM SPF 15 LIP BALM- zinc oxide stick

Badger BROAD SPECTRUM SPF 15 Lip Balm by

Drug Labeling and Warnings

Badger BROAD SPECTRUM SPF 15 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 againt sunburn and chapped lips.

Warnings

Stop use if skin rash occurs

Keep out of reach of children.

Directions

■ Apply liberally (2mg/cm 2 of skin) to lips15 minutes before sun exposure

■ Reapply at least every 2 hours. ■ For children under 6 months of age: ask a doctor.

Ingredients

*◊ Olea Europaea (Olive) Fruit Oil, *Cera Alba (Beeswax), *Theobroma Cacao (Cocoa) Seed Butter, *Butyrospermum Parkii (Shea) Butter, Tocopherol (Sunflower Vitamin E).

PRINCIPAL DISPLAY PANEL

BADGER ®

Broad Spectrum

SPF 15

LIP BALM

Unscented

Net Wt 4.2g/.15 oz

97% Organic Ingredients

INGREDIENTS AND APPEARANCE

BADGER BROAD SPECTRUM SPF 15 LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62206-4709
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: 62206-4709-8	1 in 1 BOX	01/01/2019
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	01/01/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
W.S. BADGER COMPANY, INC.		963242326	manufacture(62206-4709)