LIP BALM- sunscreen lip balm stick 
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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Napa Soap Lip Balm SPF15

Napa Soap Lip Balm SPF15

Napa Soap Lip Balm SPF15

LIP BALM 
sunscreen lip balm stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-177
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
RESVERATROL (UNII: Q369O8926L)  
SHEA BUTTER (UNII: K49155WL9Y)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62932-177-254.25 g in 1 TUBE; Type 0: Not a Combination Product11/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/19/2018
Labeler - Private Label Select Ltd CO (005415463)
Registrant - Private Label Select Ltd CO (005415463)

Revised: 11/2018
Document Id: 7adde065-a3c3-a697-e053-2991aa0a9595
Set id: 7adde065-a3c2-a697-e053-2991aa0a9595
Version: 1
Effective Time: 20181117
 
Private Label Select Ltd CO