EltaMD UV AOX Elements

Manufacturer
CP Skin Health Group, Inc | Swiss-American CDMO, LLC
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:15

Label at a glance#

ProductEltaMD UV AOX Elements
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 fr...

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.

Purpose

OTC - PURPOSE SECTION

Sunscreen

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.

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.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.4% Sunscreen
Zinc Oxide 13.5% Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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, triethoxycaprylylsilane, sodium chloride, hydrogen dimethicone, sodium hyaluronate, potassium sorbate, tocopheryl acetate, tocopherol, bisabolol, carnosine, dipropylene glycol, ascorbyl palmitate, zingiber officinate (ginger) root extract, iron oxides

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-633-8872

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV AOX Elements B02522 Formula_Page_1UV AOX Elements B02522 Formula_Page_1

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
72043-2522-1EltaMD UV AOX Elements48 g in 1 BOTTLELOTION481
72043-2522-2EltaMD UV AOX Elements2 g in 1 PACKETLOTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2522ELTAMD UV AOX ELEMENTS (ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC]1Current NDC, 2 package rows20250503_d01756c0-1f82-4e08-b956-8000ecaddfd1.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-252272043-2522-1, 72043-2522-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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 AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
ndc (package): 72043-2522-2
ndc (package): 72043-2522-1
ndc (product): 72043-2522
ndc11 (package): 72043252202
ndc11 (package): 72043252201
spl id: df80438e-9164-4f29-941f-fcdfbcbc2e63
spl set id: d01756c0-1f82-4e08-b956-8000ecaddfd1

Reported adverse events (FAERS/openFDA)#

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