CIELE BLUSH AND PROTECT- zinc oxide lotion 
Ciele

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ciele Blush and Protect

Ciele Blush and Protect

PDP

CIELE BLUSH AND PROTECT 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83103-1513
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE73.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83103-1513-21 in 1 CARTON06/23/2023
1NDC:83103-1513-15.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/2023
Labeler - Ciele (105041170)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(83103-1513)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(83103-1513) , pack(83103-1513)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(83103-1513) , manufacture(83103-1513)

Revised: 7/2023
Document Id: 0162c8a1-e723-1e63-e063-6394a90a81c9
Set id: 0162c891-ba2d-a78f-e063-6394a90a156c
Version: 1
Effective Time: 20230726
 
Ciele