Badger Kids Broad Spectrum Spf 40 Natural Mineral Sunscreen Cream (Zinc Oxide) Cream [W.s. Badger Company, Inc.] -

BADGER KIDS BROAD SPECTRUM SPF 40 NATURAL MINERAL SUNSCREEN CREAM (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]
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NDC	62206-7117-7
Set ID	80a3671d-60e8-22fe-e053-2991aa0a094b
Category	HUMAN OTC DRUG LABEL
Packager	W.S. Badger Company, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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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 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.
Inactive Ingredients

Helianthus Annuus ( Sunflower) Seed Oil,*Cera Alba ( Beeswax),*Citrus Aurantium Dulcis ( Orange) Peel Oil, *Simmondsia Chinensis ( Jojoba) Seed Oil,*Citrus Tangerina ( Tangerine) Peel Oil, Tocopherol ( Sunflower Vitamin E), *Vanilla Planifolia ( Vanilla),*Hippophae Rhamnoides ( Seabuckthorn).

*= Organic
Other Information

Protect the product in this container from excessive heat and direct sunlight.
PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

Clear Sport

BADGER ®

KidsTangerine & Vanilla

Broad Spectrum
SPF 40

NATURAL MINERAL
SUNSCREEN CREAM

Safe • Effective • Hypoallergenic

WATER RESISTANT 80 min

NON GMO

CLEAR ZINC

REEF FRIENDLY

98% ORGANIC INGREDIENTS & CLEAR ZINC OXIDE

87ml/2.9 fl.oz

INGREDIENTS AND APPEARANCE

BADGER KIDS BROAD SPECTRUM SPF 40 NATURAL MINERAL SUNSCREEN CREAM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62206-7117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
ORANGE OIL (UNII: AKN3KSD11B)
MANDARIN OIL (UNII: NJO720F72R)
VANILLA (UNII: Q74T35078H)
JOJOBA OIL (UNII: 724GKU717M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62206-7117-7	87 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2019

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

Name	Address	ID/FEI	Business Operations
Establishment
W.S. BADGER COMPANY, INC.		963242326	manufacture(62206-7117)

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Medic

BADGER KIDS BROAD SPECTRUM SPF 40 NATURAL MINERAL SUNSCREEN CREAM (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]

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