BADGER KIDS SPF 30 SUNSCREEN (ZINC OXIDE) CREAM [TWINCRAFT INC]

BADGER KIDS SPF 30 SUNSCREEN (ZINC OXIDE) CREAM [TWINCRAFT INC]
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NDC	64412-4780-1
Set ID	18950101-5bd2-4ef4-9c1a-afc417d020a8
Category	HUMAN OTC DRUG LABEL
Packager	Twincraft Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

INGREDIENTS AND APPEARANCE

BADGER KIDS SPF 30 SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64412-4780
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)
ORANGE OIL (UNII: AKN3KSD11B)
MANDARIN OIL (UNII: NJO720F72R)
VANILLA (UNII: Q74T35078H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64412-4780-1	87 mL in 1 TUBE; Type 0: Not a Combination Product	12/15/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/15/2015

Labeler - Twincraft Inc (093248870)

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