EltaMD UV Replenish Broad Spectrum SPF44

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2022-07-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:57:25

Label at a glance#

ProductEltaMD UV Replenish Broad Spectrum SPF44
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 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 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every two hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularyly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the s...

Label contents#

Full prescribing information#

Warnings

WARNINGS AND PRECAUTIONS 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

If product is swallowed, get medical help or contact a Poison Control Center right away.

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 measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide   10.0%

Titanium Dioxide   5.5%

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally 15 minutes before sun exposure

reapply: after 40 minutes of swimming or sweating

immediately after towel drying

at least every two hours

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularyly 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 uner 6 months: ask a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, caprylic/capric triglyceride, C15-19 Alkane, Octyldodecyl neopentanoate, butyloctyl salicylate, cetyl dimethicone, hydrogenated polyisobutene, Mica, dimethicone, sorbitan olivate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, sodium chloride, phenoxyethanol, polyglyceryl-2 isostearate, disteardimonium hectorite, glycerin, xanthan gum, triethoxycaprylylsilane, euphorbia cerifera (Candelilla) wax, sodium hyaluronate, disodium EDTA, ethylhexyl glycerin, glyceryl behenate, silica, ascorbyl palmitate, tocopheryl acetate

Questions or Comments

OTC - QUESTIONS SECTION

call toll free 1-800-633-8872

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Replenish UCUV Replenish 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
72043-251472043-2514-2, 72043-2514-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
eae6eb3e-2ba7-4978-a3ba-26ab1cc3d01d958a763e-1bc4-473c-b5e2-5877c06136982023-09-11WarningsExact identifier
spl set id: 958a763e-1bc4-473c-b5e2-5877c0613698

Reported adverse events (FAERS/openFDA)#

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