FDA.reportPublic FDA data

EltaMD UV Sport SPF50

Manufacturer
CP Skin Health Group, Inc. | Swiss-American CDMO, LLC
Effective date
2024-05-30
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:13:15

Label at a glance#

ProductEltaMD UV Sport SPF50
Active ingredientZINC OXIDE, OCTINOXATE, octisalate
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed withother sun protection measures (See Directions) decreases the risk of skin cancer and early skin aging caued by the sun.

Dosage and administration

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

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.0%   Sunscreen
Octinoxate 7.5%   Sunscreen
Octisalate 5.0%   Sunscreen

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn If used as directed withother sun protection measures (See Directions) decreases the risk of skin cancer and early skin aging caued by the sun.

Directions

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating immedaitely after towel drying 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 10a.m.-2p.m. wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

Doseage and administration

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating immedaitely after towel drying at least every 2 hours

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Butylene Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/ 1 Dimethicone, Disodium EDTA, Hexyl Laurate, Hydrogenated Castor Oil, Iodopropynyl Butylcarbamate, Isopropyl Palmitate, Octyldoceyl Neopentaoate, Polyglyceryl-4 Isostearate, Purified Water, Sodium Chloride, Tocopheryl Acetate, 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 Sport 3oz UCUV Sport 3oz 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
72043-2287-2EltaMD UV Sport SPF502 g in 1 PACKETLOTION28
72043-2287-3EltaMD UV Sport SPF5084 g in 1 TUBELOTION848
72043-2287-6EltaMD UV Sport SPF501815 g in 1 BOTTLELOTION18158
72043-2287-8EltaMD UV Sport SPF50198 g in 1 BOTTLELOTION1988
72043-2287-9EltaMD UV Sport SPF50226 g in 1 TUBELOTION2268

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2287ELTAMD UV SPORT SPF50 (ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC.]8Current NDC, Legacy NDC, 5 package rows20240601_dffc3fde-5b6e-4a62-8289-9733be43455b.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-228772043-2287-3, 72043-2287-9, 72043-2287-8, 72043-2287-2, 72043-2287-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
octisalate4X49Y0596WACTIB
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
YELLOW WAX2ZA36H0S2VIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT

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 Sport SPF50ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREENCP Skin Health Group, Inc.dffc3fde-5b6e-4a62-8289-9733be43455b2024-05-30WarningsExact identifier
ndc (package): 72043-2287-2
ndc (package): 72043-2287-3
ndc (package): 72043-2287-6
ndc (package): 72043-2287-9
ndc (package): 72043-2287-8
ndc (product): 72043-2287
ndc11 (package): 72043228709
ndc11 (package): 72043228702
ndc11 (package): 72043228708
ndc11 (package): 72043228706
ndc11 (package): 72043228703
spl id: 872ddab8-70ef-4efc-91d9-529816ce80cb
spl set id: dffc3fde-5b6e-4a62-8289-9733be43455b

Reported adverse events (FAERS/openFDA)#

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