MEDIK8 PHYSICAL SUNSCREEN SPF 50- zinc oxide cream 
Medik8 Limited

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Medik8 Physical Sunscreen SPF 50

Drug Facts

Active ingredients

Zinc Oxide 12%

Purpose

Sunscreen

Uses

Warnings

Do not use

  • on damaged or broken skin

When using this product

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

  • if  rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

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: 

Outer LabelInner label

MEDIK8 PHYSICAL SUNSCREEN SPF 50 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79988-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79988-001-601 in 1 CARTON02/10/2021
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/10/2021
Labeler - Medik8 Limited (237907881)

Revised: 3/2024
Document Id: 14cf316f-d344-b9aa-e063-6394a90a4447
Set id: bb00b04d-2c23-6e38-e053-2a95a90a08f0
Version: 3
Effective Time: 20240329
 
Medik8 Limited