MEDIK8 PHYSICAL SUNSCREEN SPF 50- zinc oxide cream

Medik8 Physical Sunscreen SPF 50 by

Drug Labeling and Warnings

Medik8 Physical Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Pangaea Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Package Labeling: 

INGREDIENTS AND APPEARANCE

MEDIK8 PHYSICAL SUNSCREEN SPF 50 
zinc oxide cream

Product 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)