IRIS AND ROMEO WEEKEND SKIN COOL GLOW- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

Iris and Romeo Weekend Skin Cool Glow

INGREDIENTS AND APPEARANCE

IRIS AND ROMEO WEEKEND SKIN COOL GLOW 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83247-2544
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)
TIN OXIDE (UNII: KM7N50LOS6)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C26-28 ALKYL DIMETHICONE (2500 MW) (UNII: WWM99KDT6S)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
MICA (UNII: V8A1AW0880)
PHENYLPROPANOL (UNII: 0F897O3O4M)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83247-2544-2	1 in 1 CARTON	05/01/2025
1	NDC: 83247-2544-1	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	05/01/2025

Labeler - Iris and Romeo (118160130)