FDA.reportPublic FDA data

EltaMD UV Restore Tinted

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2026-04-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:54:09

Label at a glance#

ProductEltaMD UV Restore Tinted
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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. 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 fro...

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

Titanium Dioxide 2.0% Sunscreen
Zinc Oxide 15.0% Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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.

Uses

OTC - PURPOSE 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 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 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, coco-caprylate/caprate, butyloctyl salicylate, octyldodecyl neopentanoate, caprylic/capric triglyceride, methyl glucose sesquistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glycose sesquisterate, phenoxyethanol, triethoxycaprylylsilane, polyhydroxystearic acid, glycerin, saccharide isomerate, glyceryl behenate, xanthan gum, zingiber officiale (ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalene, ethylhexylglycerin, tocopheryl acetate, sclerotium gum, lecithin, pulluan, dimethicone, polysorbate 60, ethylene/methacrylate copolymer, mica, iron oxides

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-633-8872

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Restore Tinted_Page_1UV Restore Tinted_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
BarcodeEAN-130827854009924GTIN-13: 0827854009924
EAN-13: 0827854009924
GTIN-12: 827854009924
UPC-A: 827854009924
GTIN storage (14 digits): 00827854009924		UV Restore Tinted_Page_1.jpg
QR code linkQR Codecolgate.red/0001-02643-43gUV Restore Tinted_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
72043-2640-1EltaMD 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

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-264072043-2640-2, 72043-2640-4, 72043-2640-1, 72043-2640-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
METHYL GLUCOSE SESQUISTEARATEV1YW10H14DIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
PEG-20 METHYL GLUCOSE SESQUISTEARATE0345752X7UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
XANTHAN GUMTTV12P4NEEIACT
ZINGIBER CASSUMUNAR ROOT3NG517NPD8IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
SQUALANEGW89575KF9IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
BETASIZOFIRAN2X51AD1X3TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PULLULAN8ZQ0AYU1TTIACT
DIMETHICONE92RU3N3Y1OIACT
POLYSORBATE 60CAL22UVI4MIACT
MICAV8A1AW0880IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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 Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
ndc (package): 72043-2640-2
ndc (package): 72043-2640-1
ndc (package): 72043-2640-4
ndc (package): 72043-2640-3
ndc (product): 72043-2640
ndc11 (package): 72043264001
ndc11 (package): 72043264003
ndc11 (package): 72043264004
ndc11 (package): 72043264002
spl id: 8e23ebeb-73f9-4ce6-b22b-6be66e04cc86
spl set id: 6a48ad0d-20e4-44b1-90d6-30bfbc68a152

Reported adverse events (FAERS/openFDA)#

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