EltaMD UV Facial SPF30 Plus

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:03:01

Label at a glance#

ProductEltaMD UV Facial SPF30 Plus
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 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 another sun protection measures including: limit time in the sun, especially from ...

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 warm 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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%   Sunscreen

Zinc Oxide 7.0%   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 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 another sun protection measures including: limit time in the sun, especially from 10 am - 2 pm wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, petrolatum, isopropyl palmitate, octyl stearate, glyceryl stearate, cetearyl glucoside, dimethicone, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl tautrate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, ployether-1, citric 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

UV Facial UC_Page_1
UV Facial UC_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
72043-2283-2EltaMD UV Facial SPF30 Plus2 g in 1 PACKETLOTION26
72043-2283-3EltaMD UV Facial SPF30 Plus85 g in 1 TUBELOTION856
72043-2283-4EltaMD UV Facial SPF30 Plus114 g in 1 JARLOTION1146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2283ELTAMD UV FACIAL SPF30 PLUS (ZINC OXIDE AND OCTINOXATE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC.]6Current NDC, Legacy NDC, 3 package rows20231201_8426b0a0-ecd6-4486-b2da-57a950b46dc5.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-228372043-2283-3, 72043-2283-4, 72043-2283-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 Facial SPF30 PlusZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.8426b0a0-ecd6-4486-b2da-57a950b46dc52023-11-30WarningsExact identifier
ndc (package): 72043-2283-4
ndc (package): 72043-2283-3
ndc (package): 72043-2283-2
ndc (product): 72043-2283
ndc11 (package): 72043228304
ndc11 (package): 72043228302
ndc11 (package): 72043228303
spl id: e2128d85-4b31-4aa8-b9cc-8f15d61f6b34
spl set id: 8426b0a0-ecd6-4486-b2da-57a950b46dc5

Reported adverse events (FAERS/openFDA)#

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