MINERAL SUNSCREEN- zinc oxide 20% ointment 
Private Label Select Ltd Co

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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MINERAL SUNSCREEN 
zinc oxide 20% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-159
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
CASTOR OIL (UNII: D5340Y2I9G)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
JOJOBA OIL (UNII: 724GKU717M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62932-159-2388 g in 1 TUBE; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2018
Labeler - Private Label Select Ltd Co (005415463)

Revised: 3/2018
Document Id: 686b5788-c6a1-03d8-e053-2991aa0ade26
Set id: 686b5788-c6a0-03d8-e053-2991aa0ade26
Version: 3
Effective Time: 20180327
 
Private Label Select Ltd Co