FDA.reportPublic FDA data

UV RESTORE FACE SERUM SUNSCREEN SPF 50

Product NDC
87458-001
11-digit product format
874580001
Labeler code
87458
Product ID
87458-001_4b9a881a-835c-ef0c-e063-6394a90a94af
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
BETTER INNOVATION LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-25
Substance
HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
7.3; 3; 5 mg/100mL; mg/100mL; mg/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
UV RESTORE FACE SERUM SUNSCREEN SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE7.3 mg/100mL
AVOBENZONE3 mg/100mL
OCTISALATE5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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
4b9a881a-835b-ef0c-e063-6394a90a94afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87458-001-01UV RESTORE FACE SERUM SUNSCREEN SPF 501 in 1 CARTONLOTION11
87458-001-01UV RESTORE FACE SERUM SUNSCREEN SPF 5030 mL in 1 TUBELOTION301

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 153 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRO-TECT SUNSCREEN FOR PROFESSIONALSMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation374e172b-90e8-4fca-8934-dee3ed7b599d2025-12-03WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSELOCTINOXATE, ZINC OXIDEBEL STAR S A25b6cb46-6516-376a-e063-6394a90a44f62025-12-03WarningsExact identifier
application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SA4510cd0d-40b8-f452-e063-6394a90a44e52025-12-03WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC45117885-c674-b58a-e063-6394a90af5f42025-12-03WarningsExact identifier
application number: M020
CANNON BALMOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.f70a0173-c8ba-da7c-e053-6294a90a67db2025-12-03WarningsExact identifier
application number: M020
CANNON BALM 140AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEDUKE CANNON SUPPLY CO.f70c8632-ed11-0cc3-e053-6394a90a77db2025-12-03WarningsExact identifier
application number: M020
Omega-Boost Sheer Mineral SunscreenMINERAL SUNSCREENTrilogy Natural Products Limited0405b7a6-6885-ed93-e063-6294a90a93862025-12-03WarningsExact identifier
application number: M020
Poolside Hot Head SPF 30 hair scalp sunscreen mistHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517da75-c91a-1f93-e063-6394a90a65ac2025-12-03WarningsExact identifier
application number: M020
Poolside Tropic Touch SPF 30 Sunscreen Body spray.HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517ef95-8ea1-3de6-e063-6394a90a2c792025-12-03WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen oil mistHOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3%Longway Technology(Guangzhou)Co.,Ltd.4517fd05-ea60-0492-e063-6294a90a28e92025-12-03WarningsExact identifier
application number: M020
e.l.f. All Set For Sun SPF 45 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.26f43446-e5ee-57a5-e063-6394a90a86612025-12-03WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7678467a-9da3-1b51-e053-2991aa0a568f2025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECARDINAL HEALTH, INC.b60cf360-7c8d-5da4-e053-2995a90a24c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b6107d22-a992-eaa1-e053-2995a90a29c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b623defb-4a9d-6fc5-e053-2995a90ae8462025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b62329d7-29e9-d111-e053-2a95a90aab062025-12-02WarningsExact identifier
application number: M020
Leader Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECARDINAL HEALTH, INC.b5a467e0-a6ab-4136-8101-f22cc319de582025-12-02WarningsExact identifier
application number: M020
Leader General Protection SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.9544b046-055e-5886-e053-2a95a90ad09e2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44fe0844-cb74-7a04-e063-6294a90aca152025-12-02WarningsExact identifier
application number: M020
CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC44fe7468-001c-f2ee-e063-6394a90ae3b42025-12-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87458-001-01874580001011 TUBE in 1 CARTON (87458-001-01) / 30 mL in 1 TUBE1 tube2026-02-25NoNoCurrent