EltaMD UV Clear SPF46

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:02:18

Label at a glance#

ProductEltaMD UV Clear SPF46
Active ingredientZINC OXIDE, OCTINOXATE
Label structure8 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 to face and neck 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, ...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only Do not use on damaged or broken skin When using the product keep out of eyes. Rinse with water to remove Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.0% Sunscreen

Octinoxate 7.5% Sunscreen

Uses

OTC - PURPOSE 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally to face and neck 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 a.m.- 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Cyclopentasiloxane, Niacinamide, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Lactic Acid, Oleth-3 Phosphate, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane

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

RM8518 Box UC UV Clear 1.7ozRM8518 Box UC UV Clear 1.7oz

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72043-2500-1EltaMD UV Clear SPF4648 g in 1 BOTTLELOTION489
72043-2500-2EltaMD UV Clear SPF462 g in 1 PACKETLOTION29
72043-2500-3EltaMD UV Clear SPF46106 g in 1 TUBELOTION1069
72043-2500-5EltaMD UV Clear SPF4614 g in 1 BOTTLELOTION149

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-250072043-2500-1, 72043-2500-3, 72043-2500-5, 72043-2500-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 Clear SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.60438ec5-0b1f-45fd-8ce4-debfdbdc67212025-06-04WarningsExact identifier
ndc (package): 72043-2500-2
ndc (package): 72043-2500-1
ndc (package): 72043-2500-3
ndc (package): 72043-2500-5
ndc (product): 72043-2500
ndc11 (package): 72043250001
ndc11 (package): 72043250002
ndc11 (package): 72043250003
ndc11 (package): 72043250005
spl id: e1ccd02f-6246-493f-8ce5-a39b29b7bde7
spl set id: 60438ec5-0b1f-45fd-8ce4-debfdbdc6721

Reported adverse events (FAERS/openFDA)#

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