ULTRA UV PROTECTIVE MINERAL DEFENCE- zinc oxide lotion 
Ultraceuticals Pty Ltd

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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ULTRACEUTICALS Ultra UV Protective Mineral Defence SPF 50+

ULTRACEUTICALS Ultra UV Protective Mineral Defence SPF 50+

UC 100ml

ULTRA UV PROTECTIVE MINERAL DEFENCE 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10028-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE127 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISODODECANE (UNII: A8289P68Y2)  
CAFFEINE (UNII: 3G6A5W338E)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
.BETA.-TOCOPHEROL (UNII: 9U6A490501)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
CARNOSINE (UNII: 8HO6PVN24W)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10028-060-021 in 1 CARTON01/10/2020
1NDC:10028-060-01100 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:10028-060-041 in 1 CARTON01/10/2020
2NDC:10028-060-035 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/10/2020
Labeler - Ultraceuticals Pty Ltd (744068995)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(10028-060)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(10028-060) , manufacture(10028-060)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(10028-060) , pack(10028-060)

Revised: 3/2023
Document Id: f653e8ad-7c4a-19fd-e053-2a95a90a9c45
Set id: 9c36c952-0af7-8a04-e053-2a95a90a95ae
Version: 3
Effective Time: 20230307
 
Ultraceuticals Pty Ltd