MEDICUBE PDRN HYDRATING UV SERUM- homosalate, octocrylene, octisalate, ensulizole liquid

Drug Labeling and Warnings

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions
Apply liberally and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly 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

INACTIVE INGREDIENT

Water, Butyloctyl Salicylate, Propanediol, Methyl Methacrylate Crosspolymer, Benzotriazolyl Dodecyl p-Cresol, Tromethamine, Isododecane, Methyl Trimethicone, Pentylene Glycol, Polymethylsilsesquioxane, Methylpropanediol, Acrylates Copolymer, Cetearyl Alcohol, C11-13 Isoalkane, Butylene Glycol, Dipropylene Glycol, Diglycerin, Polyglyceryl-3 Methylglucose Distearate, Dimethiconol, Poly C10-30 Alkyl Acrylate, Polyacrylic Acid, 1,2-Hexanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyamide-8, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyether-1, Sphingomonas Ferment Extract, Ethylhexylglycerin, Allantoin, Sodium Stearoyl Glutamate, Biosaccharide Gum-1, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopherol, Niacinamide, Panthenol, Sodium DNA, Sodium Hyaluronate, Centella Asiatica Extract

INDICATIONS & USAGE

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

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDICUBE PDRN HYDRATING UV SERUM 
homosalate, octocrylene, octisalate, ensulizole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82440-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82440-200-01	1 in 1 BOX	05/04/2026
1		50 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	05/04/2026

Labeler - APR US INC (055675399)