Label: GOLDEN RAY SUNSCREEN (DEEP TINTED)- zinc oxide lotion
- NDC Code(s): 82184-1350-1, 82184-1350-2, 82184-1350-3
- Packager: A-Frame SunCo Inc
- 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)
- Golden Ray Sunscreen (Deep Tinted)
-
INGREDIENTS AND APPEARANCE
GOLDEN RAY SUNSCREEN (DEEP TINTED)
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82184-1350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 132 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TOCOPHEROL (UNII: R0ZB2556P8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) 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) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82184-1350-2 1 in 1 CARTON 03/08/2022 1 NDC:82184-1350-1 28 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:82184-1350-3 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/08/2022 Labeler - A-Frame SunCo Inc (118248026) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(82184-1350) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(82184-1350) , manufacture(82184-1350) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(82184-1350) , pack(82184-1350)
