SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD MATTE- 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 Protection Face Shield Matte

Sunforgettable Total Protection Face Shield Matte

PDP

SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD MATTE 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-038
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
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)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
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)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
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)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-038-021 in 1 CARTON05/17/2021
1NDC:68078-038-0155 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 finalpart35205/17/2021
Labeler - Colorescience (128731929)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(68078-038)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(68078-038) , manufacture(68078-038)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921pack(68078-038) , manufacture(68078-038)

Revised: 3/2023
Document Id: f6554be0-1d0a-3c35-e053-2a95a90a01d8
Set id: cd879b3e-16a2-2cca-e053-2a95a90a14f8
Version: 2
Effective Time: 20230307
 
Colorescience