FDA.reportPublic FDA data

EltaMD UV Daily SPF40

Product NDC
72043-2289
11-digit product format
720432289
Labeler code
72043
Product ID
72043-2289_0091fcc3-5155-4fc4-bc2e-33847ef4d77e
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide and octinoxate sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
CP Skin Health Group, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-10
Marketing end
2027-01-31
Substance
ZINC OXIDE; OCTINOXATE
Active strength
90; 75 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 packagepackage72043-228972043-2289-1DDiscontinued by firm2026-10-21

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 Daily SPF40

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE90 g/1000g
OCTINOXATE75 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
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d967b7d0-453a-4420-886a-70ecf46528d2Available 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
72043-2289-1EltaMD UV Daily SPF4048 g in 1 BOTTLELOTION487
72043-2289-2EltaMD UV Daily SPF402 g in 1 PACKETLOTION27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2289ELTAMD UV DAILY SPF40 (ZINC OXIDE AND OCTINOXATE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC.]6Current NDC, Legacy NDC, 2 package rows20231110_d967b7d0-453a-4420-886a-70ecf46528d2.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 96 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd46052d3-6f45-5f4d-e053-2995a90a87602025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc5dafd4-dfd4-d310-e053-2995a90a82a82025-12-31WarningsExact identifier
application number: M020
Coppertone EveryTone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Inc04c58384-fd82-f6d0-e063-6294a90a3ff12025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdort Inccc46b3a3-48f5-4593-e053-2995a90a87822025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport SPF 60 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb7304-789d-1f94-e063-6394a90a7e622025-12-31WarningsExact identifier
application number: M020
Coppertone Kids SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccbf9a785-f218-76fb-e053-2995a90a8e032025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60c2a38-ef92-0dff-e053-2995a90a47c42025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a5370-ec6f-42a7-e063-6394a90ac37c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd53e1253-f6a4-4f3d-e053-2a95a90a79ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Face SPF 60 Plus SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b36eb1-bffc-c31e-e063-6294a90a8eb32025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd47460a1-4768-ee44-e053-2a95a90adecf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd473e7ed-4a9f-76fe-e053-2995a90ab37d2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72043-2289-17204322890148 g in 1 BOTTLE (72043-2289-1) 48 g2018-01-100000-00-00NoNoCurrent
72043-2289-2720432289022 g in 1 PACKET (72043-2289-2) 2 g2022-07-062027-01-31NoNoCurrent