Organys Open Formula Tinted

Organys Open Formula Tinted by

Drug Labeling and Warnings

Organys Open Formula Tinted 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 OPEN FORMULA TINTED- zinc oxide lotion 
Organys Beauty

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Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

Organys Open Formula Tinted

ORGANYS OPEN FORMULA TINTED 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83612-1330
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
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)
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)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83612-1330-1	45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/29/2021

Labeler - Organys Beauty (077820778)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83612-1330)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	manufacture(83612-1330) , pack(83612-1330)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(83612-1330) , manufacture(83612-1330)

Revised: 10/2024

Document Id: 23e35a91-90d4-c81c-e063-6394a90aa8e0

34390-5

Set id: 0b3a8cc1-a496-e1e5-e063-6394a90a1c06

Version: 3

Effective Time: 20241007