CIELE BLUSH AND PROTECT JANUARY- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Ciele Blush and Protect January

Ciele Blush and Protect January

Ciele Blush and Protect January

Ciele Blush and Protect January

Ciele Blush and Protect January

Ciele Blush and Protect January

Ciele Blush and Protect January

Ciele Blush and Protect January

INGREDIENTS AND APPEARANCE

CIELE BLUSH AND PROTECT JANUARY 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83103-2059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	73.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENYLPROPANOL (UNII: 0F897O3O4M)
SODIUM SULFATE (UNII: 0YPR65R21J)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
ISOHEXADECANE (UNII: 918X1OUF1E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
RED 28 (UNII: 767IP0Y5NH)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TIN OXIDE (UNII: KM7N50LOS6)
C26-28 ALKYL DIMETHICONE (2500 MW) (UNII: WWM99KDT6S)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83103-2059-2	1 in 1 CARTON	06/23/2023
1	NDC: 83103-2059-1	5.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 83103-2059-3	2.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/26/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/23/2023

Labeler - Ciele LLC (105041170)