FDA.reportPublic FDA data

EltaMD UV Restore Tinted

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:36

Label at a glance#

ProductEltaMD UV Restore Tinted
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. 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.

Indications and 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.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2.0%

Zinc Oxide 15.0%

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, coco-caprylate/caprate, butyloctyl salicylate, caprylic/capric triglyceride, octyldodecyl neopentanoate, methyl glycose sesquistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glycose sesquistearate, phenoxyethanol, triethoxycaprylylsilane, polyhydroxystearic acid, glycerin, glyceryl behenate, saccharide isomerate, xanthan gum, zingiber officinale (Ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copoylmer, squalane, diemthicone, ethylhexylglycerin, tetrahexyldecyl ascorbate, tocopheryl acetate, sclerotium gum, lecithin, pullulan, polysorbate 60, tocopherol, mica, iron oxides

Other Infomration

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-633-8872

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Restore Tinted 1.7oz B02641UV Restore Tinted 1.7oz B02641

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 1.7oz B02641.jpg
QR code linkQR Codecolgate.red/0001-02643-43gUV Restore Tinted 1.7oz B02641.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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72043-2641-1EltaMD UV Restore Tinted48 g in 1 BOTTLELOTION481
72043-2641-2EltaMD UV Restore Tinted2 g in 1 PACKETLOTION21

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-264172043-2641-1, 72043-2641-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SCLEROTIUM GUM2X51AD1X3TIACT
PULLULAN8ZQ0AYU1TTIACT
SILICAETJ7Z6XBU4IACT
SACCHARIDE ISOMERATEW8K377W98IIACT
CITRIC ACID2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
DIMETHICONE92RU3N3Y1OIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
METHYL GLUCOSE SESQUISTEARATEV1YW10H14DIACT
PEG-20 METHYL GLUCOSE SESQUISTEARATE0345752X7UIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT
TOCOPHEROLR0ZB2556P8IACT

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, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
ndc (package): 72043-2641-1
ndc (package): 72043-2641-2
ndc (product): 72043-2641
ndc11 (package): 72043264102
ndc11 (package): 72043264101
spl id: cd956930-536b-4f76-aedb-63f68ff3516c
spl set id: 4fc18856-01b3-43ed-9e1b-b4394e31aa3c

Reported adverse events (FAERS/openFDA)#

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