FDA.reportPublic FDA data

Shield and Protect Barrier Cream

Manufacturer
Gentell LLC
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:23:48

Label at a glance#

ProductShield and Protect Barrier Cream
Active ingredientZINC OXIDE, PETROLATUM
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide

Petrolatum

Keep out of rach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water

Mineral Oil

Sodium Chloride

Hydrogenated Castor Wax

Beeswax

Imidazolidinyl Urea

Paraffin

Propylparaben

Methylparaben

Vitamin A Palmitate

Cetostearyl alcohol

Vitamin D

Vitamin E(alpha tocopherol)

Purpose

OTC - PURPOSE SECTION

Gentell Shield & Protect Moisture Barrier Cream forms a water-shedding shield thta helps soothe and protect dry or irritated skin. Theraprutic against irritation from urine, feces, and other bodily secretions. Sheild & Protect leaves skin soft and smooth rather than irretated and greasy. Ideal for sensitive skin.

Warnings

WARNINGS SECTION

For external use only

Avoid eye contact

Discontinue use and contact a physiciean if condition worsens, or symptoms persist from more than seven days

Keep this out of the reah of children

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Carefully cleanse the area and pat dry thoroughly. Apply liberally to desired areas as often as necessary or when prolonged wxposure is anticipated.

Indication and usage

INDICATIONS & USAGE SECTION

Shield & Protect Moisture Barrier Cream helps restore, replenish and soothe ry irritated or otherwise compromised skin.

It helps treat or pevent minor skin irritations assoiated with incontinence.

Protects fom and seals out wetness

Primary Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4oz

Shield and Protect Shield and Protect OintmentShield and Protect Ointment

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61554-500-012025-07-29C16284748780-1f386c649-f0dd-0266-e053-dadaa90a7c1aSheild and Protect Moisture Barrier Ointment
61554-500-012024-10-08C16284748780-1f386c649-f0dd-0266-e053-dadaa90a7c1aSheild and Protect Moisture Barrier Ointment
61554-500-012023-01-30C16284748780-1f386c649-f0dd-0266-e053-dadaa90a7c1aSheild and Protect Moisture Barrier Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61554-500-01Shield and Protect Barrier Cream118 g in 1 TUBECREAM1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61554-500SHIELD AND PROTECT BARRIER CREAM (PETROLEUM, ZINC OXIDE) CREAM [GENTELL LLC]3Legacy NDC, 1 package rows20241010_b55810f7-2c21-1941-e053-2995a90a3cd5.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-50061554-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
LIGHT MINERAL OILN6K5787QVPIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
ZINC OXIDESOI2LOH54ZACTIB
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT

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
23fbaaa1-8246-7c12-e063-6294a90a7907b55810f7-2c21-1941-e053-2995a90a3cd52024-10-08WarningsExact identifier
spl id: 23fbaaa1-8246-7c12-e063-6294a90a7907
spl set id: b55810f7-2c21-1941-e053-2995a90a3cd5

Reported adverse events (FAERS/openFDA)#

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