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
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
4.5; 9; 13.6; 2.7 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34fae072-536c-ad41-e063-6394a90af0afAvailable on FDA.report

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

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 147 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
application number: M020
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
application number: M020
Harrys Daily Facial SPF Broad SpectrumZINC OXIDEHarry's, Inc.39fdde34-45ec-bc22-e063-6394a90a7dce2025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen Brightening plus TintZINC OXIDEZEN DERMATOLOGY, INC.31e32e9c-9e0b-b678-e063-6294a90a66f52025-12-08Exact identifier
application number: M020
Healthy Mineral Sunscreen No Shine plus TintZINC OXIDEZen Dermatology, Inc.31576340-cb11-d944-e063-6294a90adef22025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen Face and BodyZINC OXIDEZen Dermatology, Inc.31e376b4-098f-34d7-e063-6394a90a17722025-12-08Exact identifier
application number: M020
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
application number: M020
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
application number: M020
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
application number: M020
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
application number: M020
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
application number: M020
Skin Apeel Pure Protect SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.18e78c7f-1523-a4f4-e063-6394a90aed972025-12-08WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
application number: M020
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
application number: M020
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
application number: M020
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
application number: M020
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
application number: M020
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
application number: M020
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
application number: M020

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 tube2025-08-01NoNoCurrent
82440-100-02824400100021 TUBE in 1 BOX (82440-100-02) / 10 mL in 1 TUBE1 tube2025-09-01YesNoCurrent