FDA Label for Medik8 Physical Sunscreen Spf 50

View Indications, Usage & Precautions

Medik8 Physical Sunscreen Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Medik8 Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredients



Zinc Oxide 12%


Purpose



Sunscreen


Uses



  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings



  • For external use only


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



  • 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



  • Protect the product in this container from excessive heat and direct sun.


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.


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