FDA.reportPublic FDA data

EltaMD UV Luminous

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2025-06-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:37:10

Label at a glance#

ProductEltaMD UV Luminous
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.

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.2% Sunscreen
Zinc Oxide 9.0% Sunscreen

Other information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, isopropyl palmitate, ethylhexyl stearate, octyldodecyl neopentanoate, perfluorononly dimethicone, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, triethoxycaprylylsilane, oleth-3 phosphate, citric acid, polysorbate 20, sorbitan isostearate, sodium hydroxide, thioctic acid, quercetin, tocopherol, iron oxides

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-633-8872

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Luminous UCUV Luminous UC

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
72043-225672043-2256-1, 72043-2256-7, 72043-2256-3

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
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYL STEARATE772Y4UFC8BIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM OXIDELMI26O6933IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
POLYSORBATE 207T1F30V5YHIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
ALPHA LIPOIC ACID73Y7P0K73YIACT
QUERCETIN9IKM0I5T1EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
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
241e1ef3-4e02-488c-9b1a-7b86f3e26a3196988ebe-c489-4d76-9e49-0d94aec5be0c2025-06-06WarningsExact identifier
spl id: 241e1ef3-4e02-488c-9b1a-7b86f3e26a31
spl set id: 96988ebe-c489-4d76-9e49-0d94aec5be0c

Reported adverse events (FAERS/openFDA)#

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