Label: SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC- zinc oxide lotion
- NDC Code(s): 68078-060-01, 68078-060-02
- 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 FACE PROTECTION FACE SHIELD CLASSIC
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INGREDIENTS AND APPEARANCE
SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 135.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) 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) NIACINAMIDE (UNII: 25X51I8RD4) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DEHYDROACETIC ACID (UNII: 2KAG279R6R) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) MALTODEXTRIN (UNII: 7CVR7L4A2D) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) ISOCETETH-10 (UNII: 1K92T9919H) DIMETHICONE (UNII: 92RU3N3Y1O) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-060-02 1 in 1 CARTON 06/10/2020 1 NDC:68078-060-01 55 mL in 1 BOTTLE, PLASTIC; 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 06/10/2020 Labeler - Colorescience (128731929) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(68078-060) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(68078-060) , manufacture(68078-060) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(68078-060) , pack(68078-060)
