NEWGEL PLUS SPF- zinc oxide, sunscreen gel 
Newmedical Technology, Inc.

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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Purpose Zinc Oxide 20% Sunscreen

Inactive Ingredients

Warnings

OTC-Keep out of Reach of Children

Zinc Oxide 20% Sunscreen

Silagen Bottle Pump 69291-6215-2Silagen CartonSilagen BottleSilagen CartonPackage Label

NEWGEL PLUS SPF 
zinc oxide, sunscreen gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69291-0850
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69291-0850-11 in 1 CARTON08/01/2016
1NDC:69291-0850-215 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2016
Labeler - Newmedical Technology, Inc. (787828669)
Registrant - Newmedical Technology, Inc. (787828669)
Establishment
NameAddressID/FEIBusiness Operations
Newmedical Technology, Inc.787828669manufacture(69291-0850)

Revised: 11/2017
Document Id: 5d67ccc0-6b15-f8f8-e053-2a91aa0a5630
Set id: 051735b9-d24c-595d-e054-00144ff88e88
Version: 5
Effective Time: 20171107
 
Newmedical Technology, Inc.