BADGER UNSCENTED BROAD SPECTRUM SPF 25 ZINC OXIDE SUNSCREEN- zinc oxide lotion
Twincraft

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Badger ® Unscented Broad Spectrum SPF 25 Zinc Oxide Sunscreen Lotion

PRINCIPAL DISPLAY PANEL - 118 ml Tube

Tube

BADGER UNSCENTED BROAD SPECTRUM SPF 25 ZINC OXIDE SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64412-4903
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SAMBUCUS NIGRA SUBSP. CERULEA FRUIT (UNII: EPM36Z6E4L)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM GLUCONATE (UNII: R6Q3791S76)
DEXTROSE (UNII: IY9XDZ35W2)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SORBITAN (UNII: 6O92ICV9RU)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
COCO GLUCOSIDE (UNII: ICS790225B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64412-4903-0	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2016	03/29/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2016	03/29/2017

Labeler - Twincraft (093248870)

Revised: 3/2017

Document Id: 4beda9d0-87db-4cc3-e054-00144ff88e88

Set id: 30c91b5f-3515-6b70-e054-00144ff8d46c

Version: 2

Effective Time: 20170330

Twincraft