CIELE TINT AND PROTECT- zinc oxide lotion

Ciele Tint and Protect by

Drug Labeling and Warnings

Ciele Tint and Protect by is a Otc medication manufactured, distributed, or labeled by Ciele, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Ciele Tint and Protect

Ciele Tint and Protect

Ciele Tint and Protect

Ciele Tint and Protect

Ciele Tint and Protect

Ciele Tint and Protect

Ciele Tint and Protect

Ciele Tint and Protect

INGREDIENTS AND APPEARANCE

CIELE TINT AND PROTECT 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83103-1819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALLANTOIN (UNII: 344S277G0Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83103-1819-2	1 in 1 CARTON	06/02/2023
1	NDC: 83103-1819-1	38 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	06/02/2023

Labeler - Ciele (105041170)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83103-1819)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	manufacture(83103-1819) , pack(83103-1819)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(83103-1819) , manufacture(83103-1819)