LIP BALM- zinc oxide lip balm 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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X3EM Tropicsport Mineral Lip Balm SPF15

X3EM Tropicsport Mineral Lip Balm SPF15

X3EM Tropicsport Mineral Lip Balm

LIP BALM 
zinc oxide lip balm ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TAMANU OIL (UNII: JT3LVK84A1)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SHEA BUTTER (UNII: K49155WL9Y)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62932-184-254 g in 1 TUBE; Type 0: Not a Combination Product11/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/23/2018
Labeler - Private Label Select Ltd CO (005415463)
Registrant - Private Label Select Ltd CO (005415463)

Revised: 11/2018
Document Id: 7b5f3b5a-deb6-972b-e053-2a91aa0a154a
Set id: 7b5f3b5a-deb5-972b-e053-2a91aa0a154a
Version: 1
Effective Time: 20181123
 
Private Label Select Ltd CO