SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC- zinc oxide lotion 
Colorescience

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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SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC

SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC

PDP

SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-060
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
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ALLANTOIN (UNII: 344S277G0Z)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISODODECANE (UNII: A8289P68Y2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
ISOCETETH-10 (UNII: 1K92T9919H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-060-021 in 1 CARTON06/10/2020
1NDC:68078-060-0155 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/10/2020
Labeler - Colorescience (128731929)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(68078-060)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(68078-060) , manufacture(68078-060)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(68078-060) , pack(68078-060)

Revised: 3/2023
Document Id: f65528d6-5697-2632-e053-2995a90af78f
Set id: d46533c7-c92d-d161-e053-2995a90a8e4b
Version: 2
Effective Time: 20230307
 
Colorescience