GOWOONSESANG HYDRA INTENSIVE BLEMISH BALM- zinc oxide cream 
GOWOONSESANG COSMETICS CO., LTD.

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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51621-096 GOWOONSESANG HYDRA INTENSIVE BLEMISH BALM

ZINC OXIDE

WATER, TITANIUM DIOXIDE, GLYCERIN, DIMETHICONE, ETC.

skin protectant


keep out or reach of the children


Apply a proper amount evenly for the last step of skin care. Use fingertips to spread gently until it has been completely absorbed.

Do not use on wounds or if you are allergic to any ingredients of this product.

Do not stay too long in the sun, even while using a sunscreen product.

for external use only


label

GOWOONSESANG HYDRA INTENSIVE BLEMISH BALM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-096
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.92 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-096-0160 mL in 1 TUBE; Type 0: Not a Combination Product04/01/201603/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/201603/23/2018
Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(51621-096)

Revised: 3/2018
Document Id: 36d0f084-65ef-40ed-932e-89420e1d7b10
Set id: 363a25a0-bb89-2e68-e054-00144ff8d46c
Version: 3
Effective Time: 20180323
 
GOWOONSESANG COSMETICS CO., LTD.