Label: ULTRACEUTICALS ULTRA UV PROTECTIVE DAILY MOISTURISING- zinc oxide lotion
- NDC Code(s): 10028-158-05, 10028-158-06
- Packager: Ultraceuticals
- 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 May 25, 2023
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- Ultraceuticals Ultra UV Protective Daily Moisturising
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INGREDIENTS AND APPEARANCE
ULTRACEUTICALS ULTRA UV PROTECTIVE DAILY MOISTURISING
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10028-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 154 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN, (+)- (UNII: XDK458E1J9) PHENYLPROPANOL (UNII: 0F897O3O4M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) .BETA.-TOCOPHEROL (UNII: 9U6A490501) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CAFFEINE (UNII: 3G6A5W338E) CARNOSINE (UNII: 8HO6PVN24W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ISOAMYL LAURATE (UNII: M1SLX00M3M) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10028-158-06 1 in 1 CARTON 05/22/2023 1 NDC:10028-158-05 75 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 05/22/2023 Labeler - Ultraceuticals (744068995)
