EltaMD Skincare UV AOX Elements SPF50 Tinted

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:32

Label at a glance#

ProductEltaMD Skincare UV AOX Elements SPF50 Tinted
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. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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...

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.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.4%
Zinc Oxide 13.5%

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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.

Other information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS

OTC - QUESTIONS SECTION

call toll free 1-800-633-8872

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, cetyl dimethicone, dimethicone PEG-10/15 crosspolymer,Polyhydroxystearic Acid, alumina, phenoxyethanol, iron oxides, Triethoxycaprylylsilane, sodium chloride, hydrogen dimethicone, sodium hyaluronate, potassium sorbate, Tocopheryl Acetate, tocopherol, bisabolol, carnosine, dipropylene glycol, ascorbyl palmitate, soidum citrate, canola oil, zingiber officinale (giner) root extract

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV AOX Elements UC_Page_1UV AOX Elements UC_Page_1

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
QR code linkQR Codecolgate.red/0001-2513-2gUV AOX Elements UC_Page_1.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
72043-2519-1EltaMD Skincare UV AOX Elements SPF50 Tinted48 g in 1 TUBELOTION482
72043-2519-2EltaMD Skincare UV AOX Elements SPF50 Tinted2 g in 1 PACKETLOTION22

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-251972043-2519-1, 72043-2519-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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 Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
ndc (package): 72043-2519-2
ndc (package): 72043-2519-1
ndc (product): 72043-2519
ndc11 (package): 72043251902
ndc11 (package): 72043251901
spl id: b6b00a32-66e0-45bb-80a8-6db4820b6d8c
spl set id: 2c74209d-9b88-4c32-ad42-cd6de16c1fef

Reported adverse events (FAERS/openFDA)#

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