IRIS AND ROMEO WEEKEND SKIN MOISTURE LIP BALM

INGREDIENTS AND APPEARANCE

IRIS AND ROMEO WEEKEND SKIN MOISTURE LIP BALM - ICONIC
zinc oxide lotion

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

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
RED 7 (UNII: ECW0LZ41X8)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
RED 40 (UNII: WZB9127XOA)
TIN OXIDE (UNII: KM7N50LOS6)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENYLPROPANOL (UNII: 0F897O3O4M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
WATER (UNII: 059QF0KO0R)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPANEDIOL (UNII: 5965N8W85T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CALCIUM SULFATE (UNII: WAT0DDB505)
SODIUM SULFATE (UNII: 0YPR65R21J)
RED 33 (UNII: 9DBA0SBB0L)
RED 28 (UNII: 767IP0Y5NH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 83247-2767-2	1 in 1 CARTON	02/21/2025
1	NDC: 83247-2767-1	6.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/21/2025

Labeler - Iris and Romeo (118160130)

IRIS AND ROMEO WEEKEND SKIN MOISTURE LIP BALM - ICONIC- zinc oxide lotion