FDA.reportPublic FDA data

MEDICUBE COLLAGEN GLOW SUNSCREEN

Manufacturer
APR US INC
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:50

Label at a glance#

ProductMEDICUBE COLLAGEN GLOW SUNSCREEN
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure7 sections

Indications and uses

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.

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION

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 Ingredients

INACTIVE INGREDIENT SECTION

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, SILICA, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL, POLYGLYCERYL-3 DISTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CETEARYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM STEAROYL GLUTAMATE, BUTYLENE GLYCOL, GLYCERYL STEARATE CITRATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, XANTHAN GUM, ETHYLHEXYLGLYCERIN, CYANOCOBALAMIN, NIACINAMIDE, CERAMIDE NP, SQUALANE, TOCOPHEROL, HYDROLYZED COLLAGEN, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, CENTELLA ASIATICA EXTRACT, HYALURONIC ACID, CAPRYLYL GLYCOL, SOLUBLE COLLAGEN, ACETYL HEXAPEPTIDE-8

Indications and Usage

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

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82440-100-01MEDICUBE COLLAGEN GLOW SUNSCREEN50 mL in 1 TUBELOTION504
82440-100-01MEDICUBE COLLAGEN GLOW SUNSCREEN1 in 1 BOXLOTION14
82440-100-02MEDICUBE COLLAGEN GLOW SUNSCREEN10 mL in 1 TUBELOTION104
82440-100-02MEDICUBE COLLAGEN GLOW SUNSCREEN1 in 1 BOXLOTION14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82440-10082440-100-01, 82440-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HOMOSALATEV06SV4M95SACTIB
PROPANEDIOL5965N8W85TIACT
AVOBENZONEG63QQF2NOXACTIB

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 COLLAGEN GLOW SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC34fae072-536c-ad41-e063-6394a90af0af2025-09-03WarningsExact identifier
ndc (package): 82440-100-02
ndc (package): 82440-100-01
ndc (product): 82440-100
ndc11 (package): 82440010002
ndc11 (package): 82440010001
spl id: 3de240f2-c7c7-7bc1-e063-6294a90a2216
spl set id: 34fae072-536c-ad41-e063-6394a90af0af

Reported adverse events (FAERS/openFDA)#

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