Label: SUNFORGETTABLE TOTAL PROTECTION COLOR BALM (BRONZE)- zinc oxide stick
- NDC Code(s): 68078-035-01, 68078-035-02
- Packager: Colorescience
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Sunforgettable Total Protection Color Balm (Bronze)
-
INGREDIENTS AND APPEARANCE
SUNFORGETTABLE TOTAL PROTECTION COLOR BALM (BRONZE)
zinc oxide stickProduct 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) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(68078-035) , pack(68078-035)