Badger Spf 34 Anti-Bug Sunscreen (Zinc Oxide) Cream [Norwood Packaging Ltd.] -

BADGER SPF 34 ANTI-BUG SUNSCREEN (ZINC OXIDE) CREAM [NORWOOD PACKAGING LTD.]
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NDC	55143-103-01
Set ID	d9aa07df-c4df-412c-a7f9-321b6f58c0a1
Category	HUMAN OTC DRUG LABEL
Packager	Norwood Packaging Ltd.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Sunscreen Ingredient

Non-Nano Uncoated Zinc Oxide 20%
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.
Caution
For external use only

Do not use on damaged or broken skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. 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 swallowed, get medical help or contact a poison control center right away.
- Adult supervision required.
- Do not apply to children's hands.
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 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 (Extra Virgin Olive) Oil, 1Cera Alba (Beeswax), 1Ricinus Communis (Castor) Oil, 1Cymbopogon Nardus (Citronella) Oil, 1Cymbopogon Schoenanthus (Lemongrass) Oil, 1Cedrus Deodara (Cedar) Oil,1Rosmarinus Officinalis (Rosemary) Oil, and 1Pelargonium Graveolens (Geranium) Oil.

1

=Certified Organic
PRINCIPAL DISPLAY PANEL - 87 ml Tube Label

Active

BADGER®

DEET
FREE

Citronella & Cedar

Broad Spectrum
SPF 34

ANTI-BUG
SUNSCREEN

Tested to Repel Mosquitoes
Certified Natural • Contains 98% Organic Ingredients

WATER
RESISTANT
40 min

UVA
UVB

NON
NANO

BIO
DEGRADABLE

ACTIVE ANTI-BUG INGREDIENTS (15.5%): 10% *Castor Oil,
& Essential Oils of 2.5% *Citronella, 1.25% *Lemongrass,
1% *Cedar, 0.5% *Rosemary, & 0.25% *Geranium.

OTHER INGREDIENTS (84.5%): *Extra Virgin Olive Oil,
Zinc Oxide, *Beeswax. *= Certified Organic

87ml/2.9 fl.oz

INGREDIENTS AND APPEARANCE

BADGER SPF 34 ANTI-BUG SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55143-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
CITRONELLA OIL (UNII: QYO8Q067D0)
CEDRUS DEODARA WOOD (UNII: 1GO876QOY2)
ROSEMARY OIL (UNII: 8LGU7VM393)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55143-103-01	87 mL in 1 TUBE

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

Labeler - Norwood Packaging Ltd. (243693926)

Name	Address	ID/FEI	Business Operations
Establishment
Norwood Packaging Ltd.		243693926	MANUFACTURE(55143-103)

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Medic

BADGER SPF 34 ANTI-BUG SUNSCREEN (ZINC OXIDE) CREAM [NORWOOD PACKAGING LTD.]

Reapply

Sun Protection Measures

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