Label: SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD MATTE- zinc oxide lotion
- NDC Code(s): 68078-038-01, 68078-038-02
- 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 Face Shield Matte
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INGREDIENTS AND APPEARANCE
SUNFORGETTABLE TOTAL PROTECTION FACE SHIELD MATTE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-038 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 BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) ISOCETETH-10 (UNII: 1K92T9919H) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NIACINAMIDE (UNII: 25X51I8RD4) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) MALTODEXTRIN (UNII: 7CVR7L4A2D) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-038-02 1 in 1 CARTON 05/17/2021 1 NDC:68078-038-01 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 05/17/2021 Labeler - Colorescience (128731929) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(68078-038) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(68078-038) , manufacture(68078-038) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 pack(68078-038) , manufacture(68078-038)
