FDA.reportPublic FDA data

EltaMD UV Sheer

Product NDC
72043-2563
11-digit product format
720432563
Labeler code
72043
Product ID
72043-2563_8a66097c-9f42-4c0c-abc4-dc22b27624b6
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide and octocrylene sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
CP Skin Health Group, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-30
Substance
ZINC OXIDE; OCTOCRYLENE
Active strength
150; 100 g/1000g; g/1000g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72043-256372043-2563-1DDiscontinued by firm2026-10-23
excluded packagepackage72043-256372043-2563-2DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0572043-2563-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0572043-2563-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2672043-2563-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2672043-2563-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3172043-2563-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3172043-2563-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2872043-2563-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2872043-2563-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2172043-2563-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2172043-2563-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1072043-2563-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1072043-2563-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3172043-2563-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3172043-2563-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2072043-2563-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2072043-2563-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1072043-2563-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1072043-2563-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0872043-2563-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0872043-2563-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0372043-2563-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0372043-2563-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0972043-2563-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0972043-2563-2557ba5c1ecfa…9c80585c8c6e…

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
EltaMD UV Sheer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE150 g/1000g
OCTOCRYLENE100 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2564e811-70f5-4d00-be8e-686b55e31630Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72043-2563-0EltaMD UV Sheer10 g in 1 TUBECREAM105
72043-2563-1EltaMD UV Sheer30 g in 1 TUBECREAM305
72043-2563-2EltaMD UV Sheer2 g in 1 PACKETCREAM25
72043-2563-3EltaMD UV Sheer85 g in 1 TUBECREAM855
72043-2563-7EltaMD UV Sheer50 g in 1 TUBECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2563ELTAMD UV SHEER (ZINC OXIDE AND OCTOCRYLENE SUNSCREEN) CREAM [CP SKIN HEALTH GROUP, INC.]5Current NDC, Legacy NDC, 5 package rows20231206_2564e811-70f5-4d00-be8e-686b55e31630.zip

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 118 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72043-2563-07204325630010 g in 1 TUBE (72043-2563-0) 10 g2020-11-030000-00-00NoNoCurrent
72043-2563-17204325630130 g in 1 TUBE (72043-2563-1) 30 g2020-11-030000-00-00NoNoCurrent
72043-2563-2720432563022 g in 1 PACKET (72043-2563-2) 2 g2020-11-030000-00-00NoNoCurrent
72043-2563-37204325630385 g in 1 TUBE (72043-2563-3) 85 g2022-07-070000-00-00NoNoCurrent
72043-2563-77204325630750 g in 1 TUBE (72043-2563-7) 50 g2020-11-030000-00-00NoNoCurrent