ORGANYS DERMA MADE- zinc oxide lotion

Organys Derma Made by

Drug Labeling and Warnings

Organys Derma Made by is a Otc medication manufactured, distributed, or labeled by Organys Beauty, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Organys Derma Made

Organys Derma Made

Organys Derma Made

Organys Derma made

Organys Derma Made

Organys Derma Made

Organys Derma Made

Organys Derma Made

INGREDIENTS AND APPEARANCE

ORGANYS DERMA MADE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83612-0282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83612-0282-1	45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/24/2023	07/25/2023
2	NDC: 83612-0282-2	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2023
3	NDC: 83612-0282-3	45 mL in 1 TUBE; Type 0: Not a Combination Product	07/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/24/2023

Labeler - Organys Beauty (077820778)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83612-0282)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	manufacture(83612-0282) , pack(83612-0282)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(83612-0282) , manufacture(83612-0282)