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 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 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

1Helianthus Annuus ( Sunflower) Oil, 1Cera Alba ( Beeswax), Tocopherol ( Sunflower Vitamin E), 1Hippophae Rhamnoides ( Seabuckthorn) Fruit Extract, Iron Oxides (C.I. 77492, C.I. 77491, C.I. 77499) (and) Jojoba Esters.

1: = Certified Organic

Other Information

Protect the product in this container from excessive heat and sunlight

PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

Label

Tinted

BADGER ®

Unscented

Broad Spectrum

SPF 30

TINTED ZINC OXIDE

SUNSCREEN CREAM

Sheer Tint • For Face & Body

WATER

RESISTANT

40min

UVA

UVB

NON
NANO

98% ORGANIC INGREDIENTS

NSF

contains organic

ingredients

87ml/2.9 fl.oz

BADGER TINTED UNSCENTED SPF 30 SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62206-4741
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.75 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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62206-4741-1	87 mL in 1 TUBE; Type 0: Not a Combination Product	11/02/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/02/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
W.S. BADGER COMPANY, INC.		963242326	manufacture(62206-4741)

Badger ® Tinted Unscented SPF 30 Sunscreen Cream