FDA.reportPublic FDA data

MEDICUBE COLLAGEN GLOW SUNSCREEN

Product NDC
82440-100
11-digit product format
824400100
Labeler code
82440
Product ID
82440-100_3de240f2-c7c7-7bc1-e063-6294a90a2216
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
APR US INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2.7; 13.6; 4.5; 9 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MEDICUBE COLLAGEN GLOW SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.7 g/100mL
HOMOSALATE13.6 g/100mL
OCTISALATE4.5 g/100mL
OCTOCRYLENE9 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82440-100-01824400100011 TUBE in 1 BOX (82440-100-01) / 50 mL in 1 TUBE1 tube2025-08-01NoNoHistorical
82440-100-02824400100021 TUBE in 1 BOX (82440-100-02) / 10 mL in 1 TUBE1 tube2025-09-01YesNoHistorical