Sunforgettable Total Protection Color Balm (Bronze)

SUNFORGETTABLE TOTAL PROTECTION COLOR BALM (BRONZE)- 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 (BRONZE)
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68078-035
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	125 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
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)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68078-035-02	1 in 1 CARTON	02/01/2020
1	NDC:68078-035-01	9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2020

Labeler - Colorescience (128731929)

Registrant - Nanophase Technologies Corporation (623502044)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		050383046	api manufacture(68078-035)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		623502044	api manufacture(68078-035) , manufacture(68078-035)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		118812921	manufacture(68078-035) , pack(68078-035)