FDA.reportPublic FDA data

EltaMD UV Physical SPF41

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2026-04-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:54:06

Label at a glance#

ProductEltaMD UV Physical SPF41
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn if used as directed with other sun protection measures (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 at lest 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 int he sun, e...

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 Stop use and ask a physician if rash occurs Keep out of reach of children. 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

Uses

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at lest 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 int he sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alumina, Butylene Glycol, Citric Acid, Iodopropynyl Butylcarbamate, Iron Oxide, Isopropyl Palmitate, Lecithin, Linoleic Acid, Hydrogen Dimethicone, Octyl Stearate, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, Perfluorononyl Dimethicone, Phenoxyethanol, Polyacrylate 13, Polyisobutene, Polysorbate 20, Purified Water, Quercitin, Sodium Hydroxide, Thioctic Acid, Triethoxycaprylylsilane

KEEP OUT OF REACH OF CHILDREN 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN 

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Physical UC_Page_1UV Physical UC_Page_1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codecolgate.red/0001-02578AUV Physical UC_Page_1.jpg

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
72043-2578-2EltaMD UV Physical SPF412 g in 1 PACKETLOTION26
72043-2578-3EltaMD UV Physical SPF4185 g in 1 TUBELOTION856

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-257872043-2578-3, 72043-2578-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYL STEARATE772Y4UFC8BIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM OXIDELMI26O6933IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
POLYSORBATE 207T1F30V5YHIACT
THIOCTIC ACID73Y7P0K73YIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
QUERCETIN9IKM0I5T1EIACT
LINOLEIC ACID9KJL21T0QJIACT

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
aa984efa-cfe1-4e51-b3d4-7dbc949d2b8d2900b117-ff98-42e6-a2fc-2cd89d14ee6e2026-04-17WarningsExact identifier
spl id: aa984efa-cfe1-4e51-b3d4-7dbc949d2b8d
spl set id: 2900b117-ff98-42e6-a2fc-2cd89d14ee6e

Reported adverse events (FAERS/openFDA)#

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