FDA.reportPublic FDA data

EltaMD UV Shield SPF45

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:52:36

Label at a glance#

ProductEltaMD UV Shield SPF45
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 lest 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...

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 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 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. reapply at lest 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, Isopropyl Palmitate, Octyl Stearate, Cetearyl Alcohol, Polysorbate 60, Oleth-3 Phosphate, Phenoxyethanol, Cetearyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Polyether-1, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid, 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 Shield UCUV Shield UC

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
72043-2282-0EltaMD UV Shield SPF4510.5 g in 1 TUBELOTION10.56
72043-2282-1EltaMD UV Shield SPF4550 g in 1 TUBELOTION506
72043-2282-3EltaMD UV Shield SPF4585 g in 1 TUBELOTION856
72043-2282-8EltaMD UV Shield SPF45198 g in 1 BOTTLELOTION1986

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-228272043-2282-3, 72043-2282-8, 72043-2282-1, 72043-2282-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYL STEARATE772Y4UFC8BIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYSORBATE 60CAL22UVI4MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT

Source Document#

Source XML · Source PDF

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 Shield SPF45ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.7c49f971-d425-4be9-a665-5cd218b7f9452026-04-03WarningsExact identifier
ndc (package): 72043-2282-8
ndc (package): 72043-2282-3
ndc (package): 72043-2282-0
ndc (package): 72043-2282-1
ndc (product): 72043-2282
ndc11 (package): 72043228208
ndc11 (package): 72043228201
ndc11 (package): 72043228203
ndc11 (package): 72043228200
spl id: 04ac2d45-d2c1-4c88-9d16-65bcc66fb84e
spl set id: 7c49f971-d425-4be9-a665-5cd218b7f945

Reported adverse events (FAERS/openFDA)#

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