CIELE BRONZE AND PROTECT- zinc oxide lotion

Ciele Bronze and Protect by

Drug Labeling and Warnings

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

Drug Details [pdf]

Ciele Bronze and Protect

Ciele Bronze and Protect

Ciele Bronze and Protect

Ciele Bronze and Protect

Ciele Bronze and Protect

Ciele Bronze and Protect

Ciele Bronze and Protect

Ciele Bronze and Protect

INGREDIENTS AND APPEARANCE

CIELE BRONZE AND PROTECT 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83103-2255
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
MICA (UNII: V8A1AW0880)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83103-2255-2	1 in 1 CARTON	05/02/2024
1	NDC: 83103-2255-1	30 mL in 1 BOTTLE, DROPPER; 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	05/02/2024

Labeler - Ciele LLC (105041170)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83103-2255)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	manufacture(83103-2255) , pack(83103-2255)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	manufacture(83103-2255) , api manufacture(83103-2255)