Label: MEDIK8 PHYSICAL SUNSCREEN SPF 50- zinc oxide cream
- NDC Code(s): 79988-001-60
- Packager: Medik8 Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 29, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours.
- Sun Protections Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
Water, C12-15 Alkyl Benzoate, Coco-Caprylate, Propanediol, Butyloctyl Salicylate, Simmondsia Chinesis(Jojoba) Seed Oil, Glyceryl Behenate, Isopropyl Isostearate, Polyester-7, Squalane, Glyceryl Stearate, Neo-pentyl Glycol, Diheptanoate, Silica Silylate, Polyglyceryl-3 Ricinoleate, Isodecyl Salicylate, Dimethiconol/Propylsilesesquioxane/Silicate Crosspolymer, Trilaureth-4 Phosphate, Sodium Chloride, Allantoin, Bisabolol, Camellia Sinensis Leaf Extract, Glycerin, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Tocopherol Phenylpropanol, Caprylyl Glycol.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
MEDIK8 PHYSICAL SUNSCREEN SPF 50
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79988-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) COCO-CAPRYLATE (UNII: 4828G836N6) PROPANEDIOL (UNII: 5965N8W85T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) JOJOBA OIL (UNII: 724GKU717M) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) POLYESTER-7 (UNII: 0841698D2F) SQUALANE (UNII: GW89575KF9) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) NEOPENTYL GLYCOL (UNII: QI80HXD6S5) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) ISODECYL SALICYLATE (UNII: S7097PFP4C) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALLANTOIN (UNII: 344S277G0Z) LEVOMENOL (UNII: 24WE03BX2T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCERIN (UNII: PDC6A3C0OX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) VITIS VINIFERA SEED (UNII: C34U15ICXA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79988-001-60 1 in 1 CARTON 02/10/2021 1 60 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 Drug M020 02/10/2021 Labeler - Medik8 Limited (237907881)