PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 616)- zinc oxide lotion

pavise Lip Defense tinted hydrating oil (hue 616) by

Drug Labeling and Warnings

pavise Lip Defense tinted hydrating oil (hue 616) by is a Otc medication manufactured, distributed, or labeled by B.A.I. Biosciences INC., Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

INGREDIENTS AND APPEARANCE

PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 616) 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83100-1762
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83100-1762-2	1 in 1 CARTON	02/17/2023
1	NDC: 83100-1762-1	5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/17/2023

Labeler - B.A.I. Biosciences INC. (083612207)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83100-1762)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	pack(83100-1762)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(83100-1762) , manufacture(83100-1762)