ULTRA UV PROTECTIVE MINERAL DEFENCE- zinc oxide lotion

Ultra UV Protective Mineral Defence by

Drug Labeling and Warnings

Ultra UV Protective Mineral Defence by is a Otc medication manufactured, distributed, or labeled by Ultraceuticals Pty Ltd, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRACEUTICALS Ultra UV Protective Mineral Defence SPF 50+

INGREDIENTS AND APPEARANCE

ULTRA UV PROTECTIVE MINERAL DEFENCE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	127 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-060-02	1 in 1 CARTON	01/10/2020
1	NDC: 10028-060-01	100 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10028-060-04	1 in 1 CARTON	01/10/2020
2	NDC: 10028-060-03	5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/10/2020

Labeler - Ultraceuticals Pty Ltd (744068995)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(10028-060)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(10028-060) , manufacture(10028-060) , pack(10028-060)

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions		872684803	api manufacture(10028-060)