FDA.reportPublic FDA data

EltaMD UV Daily Tinted SPF40

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 01:54:09

Label at a glance#

ProductEltaMD UV Daily Tinted SPF40
Active ingredientZINC OXIDE, OCTINOXATE
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 to face, neck and backs of hands 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Reapply 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 t...

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 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

Octinoxate 7.5% 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 to face, neck and backs of hands 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Reapply 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 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

purified water, petrolatum, isopropyl palmitate, cetearyl glucoside, dimethicone hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, polyether-1, citric acid, oleth-3 phosphate, phenoxyethanol, butylene glycol, idodpropynyl butylcarbamate, triethoxycaprylylsilane, iron oxides, ethylhexyl stearate, octyldodecyl neopentanoate

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

02269A UV Daily Tinted New Artwork02269A UV Daily Tinted New Artwork

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/0001-02269A-48g02269A UV Daily Tinted New Artwork.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
72043-2269-1EltaMD UV Daily Tinted SPF4048 g in 1 BOTTLELOTION486
72043-2269-2EltaMD UV Daily Tinted SPF402 g in 1 PACKETLOTION26

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-226972043-2269-1, 72043-2269-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYL STEARATE772Y4UFC8BIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
DIMETHICONE92RU3N3Y1OIACT
PETROLATUM4T6H12BN9UIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT

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
9bcb8239-b933-44c6-a091-d46c32dd240db9b5f3ef-bd38-4147-847a-af79da1d9cd62026-04-17WarningsExact identifier
spl id: 9bcb8239-b933-44c6-a091-d46c32dd240d
spl set id: b9b5f3ef-bd38-4147-847a-af79da1d9cd6

Reported adverse events (FAERS/openFDA)#

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