Medik8 Physical Sunscreen Spf 50
FDA Label NDC 79988-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medik8 Limited for the product Medik8 Physical Sunscreen Spf 50 (NDC 79988-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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