CIELE SCULPT AND PROTECT- zinc oxide stick

Ciele Sculpt and Protect by

Drug Labeling and Warnings

Ciele Sculpt 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 Sculpt and Protect

Ciele Sculpt and Protect

Ciele Sculpt and Protect

Ciele Sculpt and Protect

Ciele Sculpt and Protect

Ciele Sculpt and Protect

Ciele Sculpt and Protect

Ciele Sculpt and Protect

INGREDIENTS AND APPEARANCE

CIELE SCULPT AND PROTECT 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83103-1529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	165 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
CETYL RICINOLEATE (UNII: 1P677500YD)
CANDELILLA WAX (UNII: WL0328HX19)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83103-1529-2	1 in 1 CARTON	07/07/2024
1	NDC: 83103-1529-1	150000 g in 1 CONTAINER; 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	07/07/2024

Labeler - Ciele LLC (105041170)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(83103-1529)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	pack(83103-1529) , manufacture(83103-1529)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(83103-1529) , manufacture(83103-1529)