FDA.reportPublic FDA data

EltaMD UV Restore Tinted

Product NDC
72043-2640
11-digit product format
720432640
Labeler code
72043
Product ID
72043-2640_8e23ebeb-73f9-4ce6-b22b-6be66e04cc86
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide and zinc oxide sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
CP Skin Health Group, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-15
Marketing end
2028-08-31
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
20; 150 g/1000g; g/1000g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72043-264072043-2640-2DDiscontinued by firm2026-10-23

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 Restore Tinted

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE20 g/1000g
ZINC OXIDE150 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a48ad0d-20e4-44b1-90d6-30bfbc68a152Available 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
72043-2640-1EltaMD UV Restore Tinted14 g in 1 BOTTLELOTION147
72043-2640-2EltaMD UV Restore Tinted57 g in 1 TUBELOTION577
72043-2640-3EltaMD UV Restore Tinted48 g in 1 BOTTLELOTION487
72043-2640-4EltaMD UV Restore Tinted2 g in 1 PACKETLOTION27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2640ELTAMD UV RESTORE TINTED (TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC.]6Current NDC, Legacy NDC, 4 package rows20240612_6a48ad0d-20e4-44b1-90d6-30bfbc68a152.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 106 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR SKIN BUT BETTER CC ILLUMINATION FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4e5764f3-9d9e-460b-ab1e-36f280281dec2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUMTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe700dc6e-e7ae-47ee-9974-430bfd045b4f2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCc7924d60-03fb-4a4d-b718-e324f6f1f65f2025-12-19WarningsExact identifier
application number: M020
THE GOLDEN GUARD Browning Radiance Gel Suncare for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.4654c417-faa3-23c6-e063-6394a90a2b5a2025-12-19WarningsExact identifier
application number: M020
THE MINERAL MELT Invisible Mineral Suncare for FaceTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.46557319-7546-e712-e063-6394a90a3cfe2025-12-19WarningsExact identifier
application number: M020
Sand Cloud Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff477199-9b01-fc90-e053-6294a90a51022025-12-19WarningsExact identifier
application number: M020
Sand Cloud Mineral Sunscreen For FaceTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff2346c6-d911-87b3-e053-6394a90ac6f82025-12-19WarningsExact identifier
application number: M020
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - ShellTITANIUM DIOXIDE, ZINC OXIDERodan & Fields12c63195-8707-4df0-a4d3-6f31c543db7a2025-12-19WarningsExact identifier
application number: M020
EltaMD UV SPF35OCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc3029d6ed-a60b-4789-a567-d09b12d76bf42025-12-19WarningsExact identifier
application number: M020
OUHOE Universal Colored MoisturizerTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4634fdcd-6f0e-25ca-e063-6294a90a196e2025-12-18WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
application number: M020
Sunscreen StickHOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%Foshan Sugar Max Cosmetics CO.,Ltd4637503c-46dc-68de-e063-6394a90abdc72025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe78c9ae0-c2ef-12ce-e053-2995a90abf1c2025-12-18WarningsExact identifier
application number: M020
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company248be719-edff-f40d-e063-6394a90a4ef62025-12-18WarningsExact identifier
application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company59187729-c166-58fe-e053-2991aa0abe472025-12-18WarningsExact identifier
application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60a304b1-eee5-408b-e053-2a91aa0a0a082025-12-18WarningsExact identifier
application number: M020
THE BOD GUARD Invisible Gel Sunscreen for BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.463fa1ef-d40d-d818-e063-6294a90a5e612025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe686a22f-bddc-5d7c-e053-2995a90a7b282025-12-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72043-2640-17204326400114 g in 1 BOTTLE (72043-2640-1) 14 g2022-07-072028-08-31NoNoCurrent
72043-2640-27204326400257 g in 1 TUBE (72043-2640-2) 57 g2020-09-150000-00-00NoNoCurrent
72043-2640-37204326400348 g in 1 BOTTLE (72043-2640-3) 48 g2024-06-102027-07-31NoNoHistorical
72043-2640-4720432640042 g in 1 PACKET (72043-2640-4) 2 g2020-09-152028-03-31NoNoCurrent