FDA.reportPublic FDA data

EltaMD UV Elements SPF44

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:21:13

Label at a glance#

ProductEltaMD UV Elements SPF44
Active ingredientzinc oxide, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed withother sun protection measures (See Directions) decreases the risk of skin cancer and early skin aging caued by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply after 40 minutes of swimming or sweating immedaitely after towel drying 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, e...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only Do not use on damaged or broken skin When suing 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 contact a Poison Control Center right away.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10.0% Sunscreen

Titanium Dioxide 5.5% Sunscreen

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn If used as directed withother sun protection measures (See Directions) decreases the risk of skin cancer and early skin aging caued by the sun.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn If used as directed withother sun protection measures (See Directions) decreases the risk of skin cancer and early skin aging caued by the sun.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure Reapply after 40 minutes of swimming or sweating immedaitely after towel drying 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 10a.m.-2p.m. wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, cyclopentasiloxane, dimethicone, octyldodecyl neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium hyaluronate, asorbyl palmitate, tocopherol, sodium chloride, triethoxycaprylylsilane, alumina, methicone, potassium sorbate, phenoxyethanol, citric acid, iron oxides

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 Elements UCUV Elements UC

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-251272043-2512-2, 72043-2512-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
zinc oxideSOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYALURONATE SODIUMYSE9PPT4THIACT
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONE 50THT5PCI0RIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ALUMINUM OXIDELMI26O6933IACT

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
3610bbd1-9639-4526-9e64-4b24a79cc25b215ae3e4-1fbc-4408-bcfd-79a021ac1b6e2024-01-12WarningsExact identifier
spl set id: 215ae3e4-1fbc-4408-bcfd-79a021ac1b6e

Reported adverse events (FAERS/openFDA)#

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