FDA.reportPublic FDA data

Baza Protect

Manufacturer
Coloplast Corp | Medline Industries, LP
Effective date
2026-03-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:51:48

Label at a glance#

ProductBaza Protect
Active ingredientZINC OXIDE, DIMETHICONE, UNSPECIFIED
Label structure9 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps seal out wetness.

Dosage and administration

Apply to affected area and gently wipe with clean, soft cloth. Apply as needed, especially at bedtime or any time when exposure to moisture may be prolonged.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide, 12%
Dimethicone, 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped or cracked skin.
  • Helps seal out wetness.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes.
  • Do not use on:
    • deep or puncture wounds
    • animal bites
    • serious burns.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected area and gently wipe with clean, soft cloth.
  • Apply as needed, especially at bedtime or any time when exposure to moisture may be prolonged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, petrolatum, lanolin oil, propylene glycol, PEG- 40 stearate, cetyl alcohol, PEG-8 stearate, glyceryl stearate, triacontanyl PVP, fragrance, caprylyl glycol, caprylhydroxamic acid, ethylhexylglycerin, propanediol, tocopheryl acetate, EDTA

SPL UNCLASSIFIED SECTION

Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark

Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.

PRINCIPAL DISPLAY PANEL - 142 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11701-082-24

Baza® Protect

Skin Protectant

Moisture
Barrier Cream

For Skin Irritation
Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

PRINCIPAL DISPLAY PANEL - 142 g Tube Label
PRINCIPAL DISPLAY PANEL - 142 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053158Baza Protect 1 % / 12 % Topical CreamPSN3
637565dimethicone 1 % / zinc oxide 12 % Topical CreamPSN3
1053158dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream [Baza-Protect]SBD3
637565dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical CreamSCD3
1053158Baza Protect (dimethicone 1 % / zinc oxide 12 % ) Topical CreamSY3
637565dimethicone 1 % / zinc oxide 12 % Topical CreamSY3
637565dimethicone 10 MG/ML / ZNO 120 MG/ML Topical CreamSY3
1053158dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream [Baza-Protect]SY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-082-032024-10-03C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-222024-10-03C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-242024-10-03C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-032023-01-30C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-222023-01-30C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-242023-01-30C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-082-03Baza Protect57 g in 1 TUBECREAM573
11701-082-22Baza Protect4 g in 1 PACKETCREAM43
11701-082-24Baza Protect142 g in 1 TUBECREAM1423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-082-03GM - Gram11701-0824646efbc-6072-49bc-aa13-1793008ea1f412023-09-05
11701-082-24GM - Gram11701-082a2fd9979-dee0-4f93-b7a3-a3b9742a74cc12022-03-09

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11701-08211701-082-24, 11701-082-03, 11701-082-22

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 OXIDESOI2LOH54ZACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
LANOLIN OILOVV5IIJ58FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-40 MONOSTEARATEECU18C66Q7IACT
CETYL ALCOHOL936JST6JCNIACT
PEG-8 MONOSTEARATE2P9L47VI5EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPANEDIOL5965N8W85TIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
EDETIC ACID9G34HU7RV0IACT

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
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
ndc (package): 11701-082-03
ndc (package): 11701-082-24
ndc (package): 11701-082-22
ndc (product): 11701-082
ndc11 (package): 11701008222
ndc11 (package): 11701008224
ndc11 (package): 11701008203
spl id: 7819db44-465c-4283-81fd-5f1bfd6ee11f
spl set id: 256dfcfc-a91c-49b0-9439-452586a0880e

Reported adverse events (FAERS/openFDA)#

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