BABY BARE REPUBLIC MINERAL SUNSCREEN- zinc oxide lotion 
COOLA, LLC

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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Baby Bare Republic Mineral Sunscreen

Baby Bare Republic Mineral Sunscreen

PDP

BABY BARE REPUBLIC MINERAL SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79753-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SQUALANE (UNII: GW89575KF9)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
.ALPHA.-BISABOLOL, (-)-EPI- (UNII: 37VB7WIC8L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYESTER-7 (UNII: 0841698D2F)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISODECYL SALICYLATE (UNII: S7097PFP4C)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79753-007-01100 mL in 1 TUBE; Type 0: Not a Combination Product10/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/26/2020
Labeler - COOLA, LLC (956990290)
Registrant - Nanophase Technologies Cirporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(79753-007) , pack(79753-007)

Revised: 3/2023
Document Id: f654b976-ecb5-1304-e053-2a95a90a8c74
Set id: b292d1a9-7ff8-0faf-e053-2995a90ae342
Version: 3
Effective Time: 20230307
 
COOLA, LLC