ORGANYS OPEN FORMULA SHEER- zinc oxide lotion

Organys Open Formula Sheer by

Drug Labeling and Warnings

Organys Open Formula Sheer 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 Sheer

Organys Open Formula Sheer

Organys Open Formula Sheer

Organys Open Formula Sheer

Organys Open Formula Sheer

Organys Open Formula Sheer

Organys Open Formula Sheer

Organys Open Formula Sheer

INGREDIENTS AND APPEARANCE

ORGANYS OPEN FORMULA SHEER 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83612-1391
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
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETETH-20 (UNII: I835H2IHHX)
PULLULAN (UNII: 8ZQ0AYU1TT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PHENYLPROPANOL (UNII: 0F897O3O4M)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
SQUALANE (UNII: GW89575KF9)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)
STEARETH-20 (UNII: L0Q8IK9E08)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83612-1391-1	45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/04/2021

Labeler - Organys Beauty (077820778)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	manufacture(83612-1391) , pack(83612-1391)