EltaMD UV Physical SPF41

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2024-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:36

Label at a glance#

ProductEltaMD UV Physical SPF41
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide   9.0%   Sunscreen

Titanium Dioxide   7.0%   Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Indications & Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, isopropyl palmitate, ethylkhexyl stearate, octyldodecyl neopentanoate, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, hydrogenated polyisobutene, triehtoxycaprylylsilane, oleth-3 phosphate, tocopheryl acetate, bisabolol, tocopherol, carnosine, ethylhexylglycerin, sorbitan isostearate, polysorbate 20, zingiber officinale (ginger) root extract, iron oxides

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-633-8872

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B02288 UV PhysicalB02288 UV Physical

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
72043-2588-2EltaMD UV Physical SPF412 g in 1 PACKETCREAM21
72043-2588-3EltaMD UV Physical SPF4185 g in 1 TUBECREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2588ELTAMD UV PHYSICAL SPF41 (ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN) CREAM [CP SKIN HEALTH GROUP, INC]1Current NDC, 2 package rows20240806_8fdc04eb-4079-40e3-a1b3-be4a542cf99a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-258872043-2588-3, 72043-2588-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Physical SPF41ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc8fdc04eb-4079-40e3-a1b3-be4a542cf99a2024-08-05WarningsExact identifier
ndc (package): 72043-2588-3
ndc (package): 72043-2588-2
ndc (product): 72043-2588
ndc11 (package): 72043258802
ndc11 (package): 72043258803
spl id: 5f2b9b14-b879-4ac7-9ad9-5feb96e673fa
spl set id: 8fdc04eb-4079-40e3-a1b3-be4a542cf99a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.