BADGER SPF30 UNSCENTED SUNSCREEN UNSCENTED- zinc oxide ointment

Badger SPF30 Unscented Sunscreen by

Drug Labeling and Warnings

Badger SPF30 Unscented Sunscreen by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ungredient

Non-Nano Uncoated Zinc Oxide 18.75%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn
• Reatins SPF after 40 minutes of activity in the water or perspiring
• Higher SPF gives more sunburn protection
  

Warnings:

For external use only

When using this product

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

Rash pr irritation develops and lasts

Directions:

• For full protection, apply ample white coat to all exposed skin, then rub to reduce the whitening effect.
• Some separation may occur. Knead tube before use.
• Reapply after swimming and sweating as needed.
• For children under 6 months of age: ask a doctor
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BADGER SPF30 UNSCENTED SUNSCREEN  UNSCENTED
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-201
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 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-201-01	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	11/10/2011

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture