Label: SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET- zinc oxide stick
- NDC Code(s): 68078-065-01, 68078-065-02
- 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
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- SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET
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INGREDIENTS AND APPEARANCE
SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-065 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-065-02 3 in 1 CARTON 03/07/2022 1 NDC:68078-065-01 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 03/07/2022 Labeler - Colorescience (128731929) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(68078-065) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 manufacture(68078-065) , api manufacture(68078-065) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(68078-065) , pack(68078-065)
