Label: ULTRA UV PROTECTIVE MINERAL DEFENCE- zinc oxide lotion
- NDC Code(s): 10028-060-01, 10028-060-02, 10028-060-03, 10028-060-04
- Packager: Ultraceuticals Pty Ltd
- 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)
- ULTRACEUTICALS Ultra UV Protective Mineral Defence SPF 50+
-
INGREDIENTS AND APPEARANCE
ULTRA UV PROTECTIVE MINERAL DEFENCE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10028-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 127 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ISODODECANE (UNII: A8289P68Y2) CAFFEINE (UNII: 3G6A5W338E) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) HEXYLENE GLYCOL (UNII: KEH0A3F75J) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) .BETA.-TOCOPHEROL (UNII: 9U6A490501) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) METHYLPROPANEDIOL (UNII: N8F53B3R4R) PHENYLPROPANOL (UNII: 0F897O3O4M) CARNOSINE (UNII: 8HO6PVN24W) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10028-060-02 1 in 1 CARTON 01/10/2020 1 NDC:10028-060-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10028-060-04 1 in 1 CARTON 01/10/2020 2 NDC:10028-060-03 5 mL in 1 TUBE; 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 01/10/2020 Labeler - Ultraceuticals Pty Ltd (744068995) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(10028-060) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(10028-060) , manufacture(10028-060) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(10028-060) , pack(10028-060)