SILAGEN- zinc oxide, sunscreen gel

Silagen by

Drug Labeling and Warnings

Silagen by is a Otc medication manufactured, distributed, or labeled by NewMedical Technology Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

INACTIVE INGREDIENT

WARNINGS

KEEP OUT OF REACH OF CHILDREN

ACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILAGEN 
zinc oxide, sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69291-6215
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69291-6215-1	1 in 1 CARTON	06/01/2015
1	NDC: 69291-6215-2	15 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2015

SILAGEN 
zinc oxide, sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69291-6230
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69291-6230-1	1 in 1 CARTON	06/01/2015
1	NDC: 69291-6230-2	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2015

Labeler - NewMedical Technology Inc. (787828669)

Registrant - NewMedical Technology Inc. (787828669)

Establishment
Name	Address	ID/FEI	Business Operations
NewMedical Technology Inc.		787828669	manufacture(69291-6215, 69291-6230)