BADGER KIDS SPF 30 SUNSCREEN- zinc oxide cream

Badger Kids SPF 30 Sunscreen by

Drug Labeling and Warnings

Badger Kids SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Norwood Packaging Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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/cm2 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), Essential Oils of 1Citrus Aurantium Dulcis (Sweet Orange) and 1Citrus Tangerina (Tangerine), Tocopherol (Sunflower Vitamin E), CO2 Extracts of 1Hippophae Rhamnoides (Seabuckthorn) and 1Vanilla Planifolia (Vanilla).

1 = Certified Organic

Other Information

Store at temperatures below 90°F.

PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

Active

BADGER®

Tangerine & Vanilla

Broad Spectrum
SPF 30

Kids

ZINC OXIDE
SUNSCREEN CREAM

Safe Effective Hypoallergenic

WATER
RESISTANT
40 min

UVA
UVB

NON
NANO

BIO
DEGRADABLE

NATURAL PRODUCTS ASSOCIATION
CERTIFIED

100% CERTIFIED NATURAL
98% ORGANIC INGREDIENTS

NSF
contains organic
ingredients

87ml/2.9 fl.oz

INGREDIENTS AND APPEARANCE

BADGER KIDS SPF 30 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55143-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55143-107-01	87 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2014

Labeler - Norwood Packaging Ltd. (243693926)

Establishment
Name	Address	ID/FEI	Business Operations
Norwood Packaging Ltd.		243693926	MANUFACTURE(55143-107)