SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET- zinc oxide stick 
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 COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET

SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET

PDP

SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE125 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
MICA (UNII: V8A1AW0880)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SQUALANE (UNII: GW89575KF9)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
STANNOUS OXIDE (UNII: JB2MV9I3LS)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CANDELILLA WAX (UNII: WL0328HX19)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68078-065-023 in 1 CARTON03/07/2022
1NDC:68078-065-019 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/07/2022
Labeler - Colorescience (128731929)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(68078-065)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044manufacture(68078-065) , api manufacture(68078-065)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(68078-065) , pack(68078-065)

Revised: 3/2023
Document Id: f65442f9-6f92-3425-e053-2a95a90a589a
Set id: f4aa14ed-6c6f-8301-e053-2a95a90a5e23
Version: 2
Effective Time: 20230307
 
Colorescience