FDA.reportPublic FDA data

Elta MD UV AOX Eye

Manufacturer
CP Skin Health Group, Inc.
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:14

Label at a glance#

ProductElta MD UV AOX Eye
Active ingredientZINC OXIDE
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistent sunscreen if swimming or sweating Reapply at least every 2 hours

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Use a water resistent sunscreen if swimming or sweating

Reapply at least every 2 hours

Warning

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

When using this product keep out of eye. Rinse with water to remove.

Stop use and ask a physician if rash occurs

INACTIVE INGREDIENT SECTION

Water, Diheptul Succinate, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Dimethicone Crosspolymer, Capryloyl Glycerin/Sebacic Acid Copolymer, Glycerin, Dimethicone, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Arachidyl Alcohol, Microcrystalline Cellulose, Phenoxyethanol, Albizia Julibrissin Bark Extract, Cetyl Alcohol, Tocopherol, Coco-Glucoside, Behenyl Alcohol, Butylene Glycol, Octyldodecyl Oleate, Iron Oxides, Arachidyl Glucoside, Bisabolol, Butyrospermum Parkaii (Shea) Butter, Sodium Gluconate, Theobroma Cacao (Cocoa) Seed Butter, Cellulose Gum, Ethylhexylglycerin, Isoceteth-10, Polyhydrocxystearic Acid, Silica, Sodium Hyaluronate, Pentylene, Glycol, Sodium Benzoate, Carprylyl Glycol, Darutoside, Acetyl Tetrapeptide-5, N-Prolyl Palmitoyl Tripeptide-56 Acetate

INDICATIONS & USAGE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Elta MD UV AOX Eye

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UV AOX EyeUV AOX Eye

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72043-4342-1Elta MD UV AOX Eye1 in 1 CARTONCREAM12
72043-4342-1Elta MD UV AOX Eye11 g in 1 TUBECREAM112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-4342ELTA MD UV AOX EYE (ZINC OXIDE) CREAM [CP SKIN HEALTH GROUP, INC.]2Current NDC, 2 package rows20240203_0e87b791-6ac1-dd60-e063-6394a90a658c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72043-434272043-4342-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Elta MD UV AOX EyeZINC OXIDECP Skin Health Group, Inc.0e87b791-6ac1-dd60-e063-6394a90a658c2024-01-31WarningsExact identifier
ndc (package): 72043-4342-1
ndc (product): 72043-4342
ndc11 (package): 72043434201
spl id: 104025a3-4710-12c6-e063-6294a90a1890
spl set id: 0e87b791-6ac1-dd60-e063-6394a90a658c

Reported adverse events (FAERS/openFDA)#

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