WL-AAS-Z-A-1761

WL-AAS-Z-A-1761- zinc oxide lotion
Nanophase Technologies Corporation

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.

----------

WL-AAS-Z-A-1761
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63931-4572
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
DIAMOND (UNII: 6GRV67N0U2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
PHENYLPROPANOL (UNII: 0F897O3O4M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)

Product Characteristics
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63931-4572-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	02/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/17/2023

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		050383046	api manufacture(63931-4572)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		623502044	api manufacture(63931-4572) , manufacture(63931-4572) , pack(63931-4572)