PMEUS53056R00

Manufacturer
APR US INC
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:50

Label at a glance#

ProductMEDICUBE PDRN HYDRATING UV SERUM
Active ingredientOCTISALATE, OCTOCRYLENE, ENSULIZOLE, HOMOSALATE
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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 SECTION

  • 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

OTC - PURPOSE SECTION

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82440-200-01MEDICUBE PDRN HYDRATING UV SERUM50 mL in 1 TUBELIQUID501
82440-200-01MEDICUBE PDRN HYDRATING UV SERUM1 in 1 BOXLIQUID11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82440-20082440-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDICUBE PDRN HYDRATING UV SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLEAPR US INC50a73981-985a-0a70-e063-6394a90a89cf2026-04-30WarningsExact identifier
ndc (package): 82440-200-01
ndc (product): 82440-200
ndc11 (package): 82440020001
spl id: 50a73981-985b-0a70-e063-6394a90a89cf
spl set id: 50a73981-985a-0a70-e063-6394a90a89cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.