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 87 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact identifier
application number: M020
CabanaMilk Mineral Barrier Fluid SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD47d0fe4d-ad21-1004-e063-6394a90a9c192026-01-07WarningsExact identifier
application number: M020
CENTELLA RELIEF SOOTHING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEIUNIK Co., Ltd.47d170e3-dd76-d413-e063-6294a90ae8e42026-01-07WarningsExact identifier
application number: M020
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad SpectrumZINC OXIDESEORIN COMPANY Co., Ltd.1e7cc417-3c57-c87c-e063-6394a90a670b2026-01-07WarningsExact identifier
application number: M020
Proactiv Clear Skin SPF 30AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAlchemee, LLCb0aa7ff0-f712-486f-aaaf-f88fed3b5cd12026-01-07WarningsExact identifier
application number: M020
Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEOak Essentials, LLC47d37f44-10b2-214f-e063-6294a90a5abc2026-01-07WarningsExact identifier
application number: M020
PLUMSCREEN SPF 31ZINC OXIDELe Prunier Farms, Inc.e20eb996-2b64-6bd0-e053-2a95a90a4f922026-01-07WarningsExact identifier
application number: M020
BETA-GLUCAN MILD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIUNIK Co., Ltd47d6ad8b-1081-ee21-e063-6294a90a0e632026-01-07WarningsExact identifier
application number: M020
Koobarra Mineral Face Sunscreen SPF 50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED37cf8143-99f2-cca5-e063-6394a90a19a82026-01-07WarningsExact identifier
application number: M020
Solar Swipe Mineral Sunscreen SPF50SOLAR SWIPE MINERAL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd47d75d61-5295-3eab-e063-6394a90a01c12026-01-07WarningsExact identifier
application number: M020
LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREENZINC OXIDEJANE STREET LLCdbdd3e6a-f09d-90cf-e053-2a95a90a98a02026-01-07WarningsExact identifier
application number: M020
RENEWALUXE SPF 50 SunscreenRENEWALUXE SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd1bc29960-5e73-e8ab-e063-6294a90a3f802026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREENSPF50Wild Child Laboratories PTY Ltd2767ba3e-7434-d474-e063-6294a90aa4ff2026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group5a6e622f-2c00-406a-8860-d7081656f5972026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION66c22f17-5418-42ff-97b2-33fa10f5eac32026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact 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