IRIS AND ROMEO WEEKEND SKIN BRONZE GLOW- zinc oxide lotion

Iris and Romeo Weekend Skin Bronze Glow by

Drug Labeling and Warnings

Iris and Romeo Weekend Skin Bronze Glow by is a Otc medication manufactured, distributed, or labeled by Iris and Romeo, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

Iris and Romeo Weekend Skin Bronze Glow

INGREDIENTS AND APPEARANCE

IRIS AND ROMEO WEEKEND SKIN BRONZE GLOW 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83247-2195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	110 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PYRUS MALUS (APPLE) FRUIT (UNII: B423VGH5S9)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
TIN OXIDE (UNII: KM7N50LOS6)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
MICA (UNII: V8A1AW0880)
PHENYLPROPANOL (UNII: 0F897O3O4M)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83247-2195-2	1 in 1 CARTON	02/20/2024
1	NDC: 83247-2195-1	35 mL in 1 TUBE; 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	02/20/2024

Labeler - Iris and Romeo (118160130)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83247-2195)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	pack(83247-2195) , manufacture(83247-2195)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	manufacture(83247-2195) , api manufacture(83247-2195)