SUNFORGETTABLE TOTAL PROTECTION BODY SHIELD- 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 Body Shield

Sunforgettable Total Protection Body Shield

PDP

SUNFORGETTABLE TOTAL PROTECTION BODY SHIELD 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-055
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
ISOHEXADECANE (UNII: 918X1OUF1E)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
ISODODECANE (UNII: A8289P68Y2)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
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)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-055-021 in 1 CARTON08/02/2021
1NDC:68078-055-01120 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 finalpart35208/02/2021
Labeler - Colorescience (128731929)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(68078-055)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(68078-055) , manufacture(68078-055)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(68078-055) , pack(68078-055)

Revised: 3/2023
Document Id: f6552cad-acbb-3b75-e053-2995a90a2ca8
Set id: cdb413bb-58ab-1e0f-e053-2995a90aab0f
Version: 2
Effective Time: 20230307
 
Colorescience