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

Sunforgettable Total Protection Color Balm (Bronze) by

Drug Labeling and Warnings

Sunforgettable Total Protection Color Balm (Bronze) by is a Otc medication manufactured, distributed, or labeled by Colorescience, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Sunforgettable Total Protection Color Balm (Bronze)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
.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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2020

Labeler - Colorescience (128731929)

Registrant - Nanophase Technologies Corporation (623502044)

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions		872684803	api manufacture(68078-035)