FDA.reportPublic FDA data

PROSKI SHIELD

Manufacturer
PHARMAMED USA INC
Effective date
2026-05-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
weekly-update
Hydrated at
2026-06-03 18:02:30

Label at a glance#

ProductPROSKI SHIELD
Active ingredientZINC OXIDE, DIMETHICONE
Label structure10 sections

Indications and uses

Use as a general skin protectant Helps treat and prevent diaper rash. Protects minor skin irritations associated with diaper rash, and helps seal out from wetness Dries the oozing and weeping of poison: ivy, oak, sumac

Dosage and administration

For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. For other uses: Apply as needed.

Storage and handling

Store at room temperature between 15º - 30ºC (59º - 86ºF) Avoid excessive heat Tamper evident. Do not use if the seal is damaged.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 2%

Dimethicone 1.8%

Purpose

OTC - PURPOSE SECTION

  • Diaper rash
  • Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Use as a general skin protectant
  • Helps treat and prevent diaper rash. Protects minor skin irritations associated with diaper rash, and helps seal out from wetness
  • Dries the oozing and weeping of poison: ivy, oak, sumac

Warnings

WARNINGS SECTION

For External Use Only.

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Do not use over large areas of the body
  • So not use if you are alergic to any of the ingredients

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • For other uses: Apply as needed.

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature between 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if the seal is damaged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), CETETH-20, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Yellow 5, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Petrolatum

Questions and Comments?

OTC - QUESTIONS SECTION

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

Recent Major Changes (§ 201.57(a)(5)) Rev. 05-01-2026

RECENT MAJOR CHANGES SECTION

• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 84289-408-02

SKIN PROTECTANT BARRIER CREAM WITH 2% ZINC OXIDE ANS 1,8% DIMETHICONE

■ Aloe Soft ■ Vitamin Enriched ■ Vitamin A ■ Vitamin D3 ■ Vitamin E ■ Aloe Vera

Contains Aloe Vera

Net Wt 4 oz. (113 g)

GO/DRUGS/571

Inner Label ImageInner Label Image

Pinted InsertPinted Insert

DailyMed Product Concepts#

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

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
84289-40884289-408-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OACTIB
TROLAMINE9O3K93S3TKIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
CHOLECALCIFEROL1C6V77QF41IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
VITAMIN A ACETATE3LE3D9D6OYIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
CETETH-20I835H2IHHXIACT
LAVENDER OILZBP1YXW0H8IACT
YELLOW 5I753WB2F1MIACT
METHYLPARABENA2I8C7HI9TIACT
CETYL ALCOHOL936JST6JCNIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT

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
525a0182-a850-3e7b-e063-6294a90a5d8a2c7768a6-5859-74ca-e063-6394a90a8ef32026-05-21WarningsExact identifier
spl set id: 2c7768a6-5859-74ca-e063-6394a90a8ef3

Reported adverse events (FAERS/openFDA)#

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