Label: SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD, GLOW- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68078-032-01, 68078-032-02 - 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 February 18, 2020
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- Sunforgettable Total Protection Face Shield Glow
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INGREDIENTS AND APPEARANCE
SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD, GLOW
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 134.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) DIMETHICONE (UNII: 92RU3N3Y1O) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ALLANTOIN (UNII: 344S277G0Z) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-032-02 1 in 1 CARTON 01/01/2019 1 NDC:68078-032-01 55 mL in 1 BOTTLE; 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 01/01/2019 Labeler - Colorescience (128731929) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(68078-032) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(68078-032) , manufacture(68078-032) , pack(68078-032)
