BADGER SPF 35 KIDS ALL SEASON- zinc oxide stick

Badger SPF 35 Kids All Season by

Drug Labeling and Warnings

Badger SPF 35 Kids All Season 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 22.5%

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 use 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 exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.

Reapply:

• After 80 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 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 ( Olive) Fruit Oil, 1Cera Alba ( Beeswax), 1Theobroma Cacao ( Cocoa) Seed Butter, 1Butyrospermum Parkii ( Shea) Butter, 1Citrus Aurantium Dulcis ( Sweet Orange) Peel Oil, 1Citrus Tangerina ( Tangerine) Peel Oil, Tocopherol ( Sunflower Vitamin E), 1Vanilla Planifolia ( Vanilla) Fruit Extract.

1 = Certified Organic.

Other Information

Store at temperatures below 90ºF.

PRINCIPAL DISPLAY PANEL - 18.4 g Applicator Box

Sport

BADGER ®

Kids

Tangerine & Vanilla

Broad Spectrum

SPF 35

ZINC OXIDE

SUNSCREEN

ALL SEASON

FACE STICK

On-the-Go Spot Protection

for Active Play

WATER

RESISTANT

80min

UVA

UVB

NON

NANO

BIO

DEGRADABLE

NATURAL PRODUCTS ASSOCIATION

CERTIFIED

100% CERTIFIED NATURAL

98% ORGANIC INGREDIENTS

NSF

contains organic

ingredients

Net Wt 18.4g/.65oz

INGREDIENTS AND APPEARANCE

BADGER SPF 35 KIDS ALL SEASON 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62206-4721
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.5 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)
ORANGE OIL (UNII: AKN3KSD11B)
MANDARIN OIL (UNII: NJO720F72R)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62206-4721-1	1 in 1 BOX	07/16/2018
1		18.4 g in 1 TUBE; 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	10/01/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
W.S. BADGER COMPANY, INC.		963242326	manufacture(62206-4721)