BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 25 FACE SUNSCREEN - SHEER TINT- 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 ® Damascus Rose Broad Spectrum SPF 25 Face Sunscreen - Sheer Tint

PRINCIPAL DISPLAY PANEL - 47 ml Tube Box

Label

Box

BADGER DAMASCUS ROSE BROAD SPECTRUM SPF 25 FACE SUNSCREEN - SHEER TINT
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64412-4904
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCO GLUCOSIDE (UNII: ICS790225B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SAMBUCUS NIGRA SUBSP. CERULEA FRUIT (UNII: EPM36Z6E4L)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
GLYCERIN (UNII: PDC6A3C0OX)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
LAVENDER OIL (UNII: ZBP1YXW0H8)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM GLUCONATE (UNII: R6Q3791S76)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
POMEGRANATE (UNII: 56687D1Z4D)
DEXTROSE (UNII: IY9XDZ35W2)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
SORBITAN (UNII: 6O92ICV9RU)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64412-4904-4	1 in 1 BOX	02/01/2016	03/29/2017
1		47 mL in 1 TUBE; Type 0: Not a Combination Product

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: 4bedcf67-b8e4-56fa-e054-00144ff88e88

Set id: 30c9c2b2-4365-0d4a-e054-00144ff8d46c

Version: 2

Effective Time: 20170330

Twincraft