FDA.reportPublic FDA data

CMC SHIELD SKIN PROTECTANT

Manufacturer
SKYLARK CMC PRIVATE LIMITED
Effective date
2017-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:29

Label at a glance#

ProductCMC SHIELD SKIN PROTECTANT
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash temporarily protects from minor cuts, scrapes burns dries the oozing and weeping of poison ivy, poison oak, poison sumac

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged for poison ivy, oak, and sumac apply ointment liberally as needed

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (3.8%)

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • temporarily protects from minor cuts, scrapes
  • burns dries the oozing and weeping of poison ivy, poison oak, poison sumac

WARNINGS

WARNINGS SECTION

For external use only

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • do not get into eyes

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

Condition worsens or symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

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 right away

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • for poison ivy, oak, and sumac
  • apply ointment liberally as needed

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store at a room temperature 15-30° C (59-86 F)
  • Avoid excessive heat

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin-A, water, FDC Yellow No. 5, DC Red No.21

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAYPRINCIPAL DISPLAYDRUG FACT PANELDRUG FACT PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1865206zinc oxide 3.8 % Topical CreamPSN1
1865206zinc oxide 38 MG/ML Topical CreamSCD1
1865206zinc oxide 3.8 % Topical CreamSY1
1865206ZNO 38 MG/ML Topical CreamSY1

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
71168-3066-42020-01-31C16284748780-19d75b9d0-091c-f424-e053-dadaa90a57ceCMC-SHIELD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71168-3066-4CMC SHIELD SKIN PROTECTANT99.2 g in 1 TUBECREAM99.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71168-3066CMC SHIELD SKIN PROTECTANT (ZINC OXIDE) CREAM [SKYLARK CMC PRIVATE LIMITED]1Legacy NDC, 1 package rows20170912_58fffc68-579e-0dfc-e053-2991aa0afb27.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71168-306671168-3066-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROLH4N855PNZ1IACT
METHYLPARABENA2I8C7HI9TIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
STEARETH-20L0Q8IK9E08IACT
TROLAMINE9O3K93S3TKIACT
VITAMIN A81G40H8B0TIACT
WATER059QF0KO0RIACT
D&C RED NO. 2108744Z6JNYIACT
CETYL ALCOHOL936JST6JCNIACT
LAVENDER OILZBP1YXW0H8IACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ZINC OXIDESOI2LOH54ZACTIB
CETETH-10LF9X1PN3XJIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHOLECALCIFEROL1C6V77QF41IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT

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
58fffc68-579f-0dfc-e053-2991aa0afb2758fffc68-579e-0dfc-e053-2991aa0afb272017-09-12WarningsExact identifier
spl id: 58fffc68-579f-0dfc-e053-2991aa0afb27
spl set id: 58fffc68-579e-0dfc-e053-2991aa0afb27

Reported adverse events (FAERS/openFDA)#

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