NDC 53208-549

SOORYEHAN HYO FERMENTED SUN BLOCK

Zinc Oxide, Titanium Dioxide, Ensulizole

SOORYEHAN HYO FERMENTED SUN BLOCK is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Lg Household And Healthcare, Inc.. The primary component is Octinoxate; Titanium Dioxide; Amiloxate; Bemotrizinol; Diethylamino Hydroxybenzoyl Hexyl Benzoate; Ensulizole; Tromethamine.

Product ID53208-549_b6962d6b-f69c-4375-8bdc-4c1a1853552b
NDC53208-549
Product TypeHuman Otc Drug
Proprietary NameSOORYEHAN HYO FERMENTED SUN BLOCK
Generic NameZinc Oxide, Titanium Dioxide, Ensulizole
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2011-09-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameLG Household and Healthcare, Inc.
Substance NameOCTINOXATE; TITANIUM DIOXIDE; AMILOXATE; BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ENSULIZOLE; TROMETHAMINE
Active Ingredient Strength7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53208-549-02

1 CONTAINER in 1 BOX (53208-549-02) > 60 mL in 1 CONTAINER (53208-549-01)
Marketing Start Date2011-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53208-549-02 [53208054902]

SOORYEHAN HYO FERMENTED SUN BLOCK CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-27
Inactivation Date2019-10-29

NDC 53208-549-01 [53208054901]

SOORYEHAN HYO FERMENTED SUN BLOCK CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-27

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7 mL/100mL

OpenFDA Data

SPL SET ID:e6937dda-afe6-4f65-83e8-1a5a6ba15390
Manufacturer
UNII

NDC Crossover Matching brand name "SOORYEHAN HYO FERMENTED SUN BLOCK" or generic name "Zinc Oxide, Titanium Dioxide, Ensulizole"

NDCBrand NameGeneric Name
53208-549SOORYEHAN HYO FERMENTED SUN BLOCKZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE
53208-538OHUI SUN SCIENCE Perfect Sunblock black EX plusZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.