SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD FLEX- zinc oxide lotion 
Nanophase Technologies Corporation

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.

----------

Sunforgettable Total Protection Face Shield Flex

Sunforgettable Total Protection Face Shield Flex

PDP

SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD FLEX 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE135.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISODODECANE (UNII: A8289P68Y2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
ISOCETETH-10 (UNII: 1K92T9919H)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
MICA (UNII: V8A1AW0880)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ZEIN (UNII: 80N308T1NN)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-042-021 in 1 CARTON05/06/2021
1NDC:68078-042-0155 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/06/2021
Labeler - Nanophase Technologies Corporation (128731929)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(68078-042)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(68078-042) , manufacture(68078-042)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921pack(68078-042) , manufacture(68078-042)

Revised: 3/2023
Document Id: f6556e35-2e50-1e1d-e053-2995a90a3ff2
Set id: cdb55347-aedd-4de6-e053-2a95a90afec7
Version: 4
Effective Time: 20230307
 
Nanophase Technologies Corporation