medik8 physical sunscreen spf 50

medik8 physical sunscreen spf 50
SPL v3
SPL
SPL Set ID bb00b04d-2c23-6e38-e053-2a95a90a08f0
Route
topical
Published
Effective Date 2021-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (120 mg)
Inactive Ingredients
water alkyl (c12-15) benzoate coco-caprylate propanediol butyloctyl salicylate jojoba oil isopropyl isostearate polyester-7 squalane glyceryl monostearate neopentyl glycol polyglyceryl-3 ricinoleate isodecyl salicylate trilaureth-4 phosphate sodium chloride allantoin levomenol green tea leaf glycerin hyaluronate sodium vitis vinifera seed caprylyl glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-02-10

Purpose

Sunscreen

Description

Zinc Oxide 12%


Medication Information

Warnings
  • For external use only

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
Purpose

Sunscreen

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.

Description

Zinc Oxide 12%

Do Not Use
  • on damaged or broken skin
Drug Facts

Active Ingredients

Zinc Oxide 12%

Package Labeling: 

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


Structured Label Content

Warnings
  • For external use only

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
Purpose

Sunscreen

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 (Other information)
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients (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.

Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

Active Ingredients (Active ingredients)

Zinc Oxide 12%

Package Labeling: 

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if  rash occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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