DAYBIRD TINTED SKINCARE (SHADE 2)- zinc oxide lotion 
Resette, Inc

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.

----------

Daybird Tinted Skincare (SHADE 2)

Daybird Tinted Skincare (SHADE 2)

PDP

DAYBIRD TINTED SKINCARE (SHADE 2) 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82417-1063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SQUALANE (UNII: GW89575KF9)  
RUTIN (UNII: 5G06TVY3R7)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
JOJOBA OIL (UNII: 724GKU717M)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
NYLON-12 (UNII: 446U8J075B)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
ALLANTOIN (UNII: 344S277G0Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82417-1063-21 in 1 CARTON04/12/2022
1NDC:82417-1063-130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/12/2022
Labeler - Resette, Inc (118304424)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(82417-1063)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(82417-1063) , manufacture(82417-1063)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(82417-1063) , pack(82417-1063)

Revised: 3/2023
Document Id: f6548278-9550-2b5c-e053-2a95a90a72cc
Set id: dc89ab76-da2f-4f6f-e053-2995a90a8bcb
Version: 2
Effective Time: 20230307
 
Resette, Inc