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 274 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f540b0f6-3e6c-43a7-e053-2a95a90aba742024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town CityLIP BALM SPF 30 SUNSCREEN STICKFruit of the Earth, Inc.3ec16996-ae86-4f5b-b1fd-c7b509cc5d502024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452df0c-ea8d-e25c-e053-2995a90a11432024-10-18WarningsExact identifier
application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFRUIT OF THE EARTH, INC.fa18f1a9-7a6a-856e-e053-6294a90aeafa2024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452f94a-d2f1-60ec-e053-2995a90a88272024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f53fff7a-ef8b-19c4-e053-2a95a90a4a2a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFruit Of The Earth, Inc.fd68012d-814b-ac07-e053-6394a90afc682024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd687b34-e4c6-0458-e053-6394a90ac0642024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd786a06-88b7-fa35-e053-6394a90a84a52024-10-18WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50 with AntipollutionHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREENSwiss-American CDMO, LLC59efb7dd-83f9-4222-9b7e-ea17ac4ece002024-10-18WarningsExact identifier
application number: M020
CVS Health SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyf0d6ac48-3d57-0f5c-e053-2a95a90a87cf2024-10-17WarningsExact identifier
application number: M020
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf13f7361-56b3-7ea8-e053-2995a90a76412024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 50 Ultra ProtectionAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf11650bb-90a0-78a1-e053-2995a90a8e4c2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyf31dd448-dc79-21f1-e053-2a95a90a7bb62024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Breakout Free FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41478c8-76c0-727f-e053-2a95a90a86692024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra ProtectionAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf12ba764-afea-3f81-e053-2a95a90a12912024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf40e5664-e3ca-badf-e053-2a95a90a913e2024-10-17WarningsExact 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