EltaMD UV Active

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:41

Label at a glance#

ProductEltaMD UV Active
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply after 80 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, regularly use sunscreen with a broad-spectrum SPF value of 15 or higher. Limit time in the sun, especially from 10 am to 2 pm. Wear...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Stop use and ask physician if rash occurs. When using this product keep out of eyes. Rinse with water to remove. 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.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide   19.0%   Sunscreen

Titanium Dioxide   4.0%   Sunscreen

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 80 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, regularly use sunscreen with a broad-spectrum SPF value of 15 or higher. Limit time in the sun, especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Questions

OTC - QUESTIONS SECTION

Questions or Comments?

1-800-633-8872

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, caprylic/capric trigylceride, coco-caprylate/caprate, ethyl macadamiate, glycerin, sorbitan olivate, polyglyceryl-6 polyricinoleate, C15-19 alkane, hydrogenated polyisobutene, sodium chloride, triethoxycaprylylsilane, silica, glyceryl beheanate, hydroxyacetophenone, polyglyceryl-2 isostearate, polyhydroxysearic acid, disteardimonium hectorite, 1,2-hexanediol, caprylyl glycol, hydrolyzed jojoba esters, xanthan gum, diemthicone, sclerotium gum, trisodium ethylenediamine disuccinate, lecithin, pullulan, jojoba esters, polygonum aviculare extract, tocopherol, malic acid 

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV Active UC 3oz TubeUV Active UC 3oz Tube

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
72043-2600-2EltaMD UV Active2 g in 1 PACKETCREAM24
72043-2600-3EltaMD UV Active90 g in 1 TUBECREAM904
72043-2600-8EltaMD UV Active234 g in 1 TUBECREAM2344

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2600ELTAMD UV ACTIVE (ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN) CREAM [CP SKIN HEALTH GROUP, INC.]4Current NDC, Legacy NDC, 3 package rows20231110_2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-260072043-2600-3, 72043-2600-2, 72043-2600-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
EltaMD UV ActiveZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd22023-11-09WarningsExact identifier
ndc (package): 72043-2600-8
ndc (package): 72043-2600-2
ndc (package): 72043-2600-3
ndc (product): 72043-2600
ndc11 (package): 72043260003
ndc11 (package): 72043260008
ndc11 (package): 72043260002
spl id: 3c3c0d5a-342d-4a67-bed9-40dcd39f3869
spl set id: 2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2

Reported adverse events (FAERS/openFDA)#

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