FDA.reportPublic FDA data

Mediheal Madecassoside Moisture Sun Serum

Product NDC
74005-002
11-digit product format
740050002
Labeler code
74005
Product ID
74005-002_5182f119-832d-4deb-e063-6294a90af415
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Octisalate, Ensulizole
Dosage form
LOTION
Route
TOPICAL
Labeler
74005
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
HOMOSALATE; ENSULIZOLE; OCTOCRYLENE; OCTISALATE
Active strength
5; 2.5; 5; 4.5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Mediheal Madecassoside Moisture Sun Serum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5 g/100mL
ENSULIZOLE2.5 g/100mL
OCTOCRYLENE5 g/100mL
OCTISALATE4.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
9YQ9DI1W42Internal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47c66535-8287-9b74-e063-6394a90ac3b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74005-002-01Mediheal Madecassoside Moisture Sun Serum1 in 1 BOXLOTION12
74005-002-01Mediheal Madecassoside Moisture Sun Serum50 mL in 1 CONTAINERLOTION502
74005-002-02Mediheal Madecassoside Moisture Sun Serum1 in 1 BOXLOTION12
74005-002-02Mediheal Madecassoside Moisture Sun Serum15 mL in 1 CONTAINERLOTION152

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 99 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUTURIST SKIN TINT SERUMOCTINOXATE,OCTISALATE,ZINC OXIDEESTEE LAUDER INCea21e5a5-69d6-2de4-e053-2995a90a93b42025-12-31WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
application number: M020
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEFormula 7venz L.L.C.e8e350e7-9225-4802-89a6-66e45ebc442d2025-12-31WarningsExact identifier
application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35Kinfield, Inc.0710db9f-fe91-4b98-a337-5fde33d98a9d2025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.1030c5a4-3067-48e6-a21c-0d327ef434d02025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.612c5730-c3b4-486e-8ce9-8a861f676fa82025-12-30WarningsExact identifier
application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum SunscreenKINFIELD LIPLOCK SUNSCREENKinfield, Inc.477aa1a2-c893-4750-84da-e5afe7ccd45b2025-12-30WarningsExact identifier
application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.cbdfd0ae-514b-4b53-98ad-4270163bd0df2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDECLINIQUE LABORATORIES LLC2397aca5-bf0a-619d-e063-6394a90a7ab92025-12-30WarningsExact identifier
application number: M020
Resource Essentials Sun Protection Mineral SPF 3014% ZINC OXIDESkinresource.md, L.L.C.45b486cf-28ee-6392-e063-6394a90affb02025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47313277-8884-70b5-e063-6394a90a5fca2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47320858-0aea-6ee9-e063-6294a90a9fa92025-12-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74005-002-01740050002011 CONTAINER in 1 BOX (74005-002-01) / 50 mL in 1 CONTAINER1 container2026-05-01NoNoCurrent
74005-002-02740050002021 CONTAINER in 1 BOX (74005-002-02) / 15 mL in 1 CONTAINER1 container2026-05-01NoNoCurrent
74005-002-03740050002032 CONTAINER in 1 BOX (74005-002-03) / 50 mL in 1 CONTAINER2 container2026-08-10NoNoCurrent
74005-002-04740050002043 CONTAINER in 1 BOX (74005-002-04) / 115 mL in 1 CONTAINER3 container2026-08-10NoNoCurrent