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 firm2026-10-16

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 24 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLEL'Oreal USA Products Inc79fd34ad-cd4a-4fa0-9b7c-e0a2252654da2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLESICOS ET CIE3ff286c0-4515-4cab-9b93-a782545b2f362026-05-27WarningsExact identifier
application number: M020
MyDerm SPF 50HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Inspec Solutions LLC1a995cda-dc67-419c-90e6-c61050c760982026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc2b634b3f-0d2b-4ae4-b302-9befb14a90df2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEfce593a2-f4ed-46c1-81a1-be3941649e472026-05-27WarningsExact identifier
application number: M020
BROTEGE Good Boy Protection SPF 15 and Retinol Daily MoisturizerBENZOPHENONE-3, BUTYLE METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENESpa de Soleil1f47e508-58dd-fab4-e063-6394a90a668a2026-05-27WarningsExact identifier
application number: M020
GOONGBE Waterful SunLotion Mild SPF 40ZINC OXIDEZero to Seven Inc.1e86edfd-d089-ba41-e063-6294a90a67092026-05-27WarningsExact identifier
application number: M020
GOONGBE Baby Easy Wash SunLotion SPF 30ZINC OXIDEZero to Seven Inc.1e86c2a9-a5c3-95cb-e063-6394a90a014d2026-05-27WarningsExact identifier
application number: M020
Stream2Sea Reef Safer Mineral Sunscreen SPF40ZINC OXIDEStream2Sea, LLC52e73c23-75ec-d8a8-e063-6294a90a54932026-05-27WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDERiversol52b8f588-8383-634e-e063-6294a90a8f8b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDERiversol52b92725-6d9a-768a-e063-6394a90ac9332026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Jazzy BerryZINC OXIDEOdacite52b97fb0-84d6-a408-e063-6294a90a9be92026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - True NudeZINC OXIDEOdacite52b9be2a-4958-f537-e063-6294a90a7a1b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDESolesence, Inc.52ba09cb-edcc-a405-e063-6394a90a6aab2026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Bubble GumZINC OXIDEOdacite52b9fb0a-0554-0de2-e063-6294a90a09d32026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDESolesence, Inc.52ba07f1-b74e-a4b6-e063-6394a90a74732026-05-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 SunscreenZINC OXIDESKIN DAMAGE INC.52ba2f12-839f-cea1-e063-6394a90a5ae62026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Bronze JolieZINC OXIDEOdacite52ba360e-375c-0469-e063-6294a90a020e2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Golden HourZINC OXIDEOdacite52ba8e03-1944-b73d-e063-6294a90a50392026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact 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