DERMA DR. LAB HYDROMOIST COVER BB- 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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Drug Facts

zinc oxide

water, titanium dioxide, and etc.

skin protectant


keep out or reach of the children


apply proper amount to the skin


1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children


for external use only


Label

DERMA DR. LAB HYDROMOIST COVER BB 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-089
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-089-0145 mL in 1 TUBE; Type 0: Not a Combination Product01/02/201803/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/201803/23/2018
Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Establishment
NameAddressID/FEIBusiness Operations
Biocostec Co., Ltd.690407325manufacture(51621-089)

Revised: 3/2018
 
GOWOONSESANG COSMETICS CO., LTD.