FDA.reportPublic FDA data

Benchmarks Derma Shield

Manufacturer
STAR COLOUR LABORATORIES
Effective date
2020-10-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:22

Label at a glance#

ProductBenchmarks Derma Shield
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin Helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

Apply as needed Children under 6 months: ask a doctor Wash and dry skin area Shake can vigorously Invert can and apply "golf ball" sized amount in palm Rub thoroughly onto the skin Allow to dry

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Dimethicone, 2.7%

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather

Purpose

OTC - PURPOSE SECTION

Skin protectant

Warnings

WARNINGS SECTION

For external use only

Flammable:

  • Do not use near flame or spark or while smoking
  • Contents under pressure
  • Do not puncture or incinerate
  • Do not store at temperature above 120oF

Do not use on:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns
  • keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed
  • Children under 6 months: ask a doctor
  • Wash and dry skin area
  • Shake can vigorously
  • Invert can and apply "golf ball" sized amount in palm
  • Rub thoroughly onto the skin
  • Allow to dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, Glycerin, VP/VA Copolymer, Isobutane, Triethanolamine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Hydroxyethylcellulose, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Derma Shield 2oz Aerosol USA

Outer label for Derma Shield 2oz AerosolOuter label for Derma Shield 2oz Aerosol

Derma Shield 6oz Aerosol USA

Outer label for Derma Shield 6oz AerosolOuter label for Derma Shield 6oz Aerosol

Derma Shield 17oz Aerosol USA

Outer label for Derma Shield 17oz AerosolOuter label for Derma Shield 17oz Aerosol

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80905-001-012022-01-28C16284748780-1d6a99b39-fe62-a426-e053-dadaa90af4c2a2d586e2-352e-4fea-a95e-85b089f1dda3
80905-001-022022-01-28C16284748780-1d6a99b39-fe62-a426-e053-dadaa90af4c2a2d586e2-352e-4fea-a95e-85b089f1dda3
80905-001-032022-01-28C16284748780-1d6a99b39-fe62-a426-e053-dadaa90af4c2a2d586e2-352e-4fea-a95e-85b089f1dda3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80905-001-01Benchmarks Derma Shield57 g in 1 CANAEROSOL571
80905-001-02Benchmarks Derma Shield170 g in 1 CANAEROSOL1701
80905-001-03Benchmarks Derma Shield482 g in 1 CANAEROSOL4821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80905-001BENCHMARKS DERMA SHIELD (DIMETHICONE) AEROSOL [STAR COLOUR LABORATORIES]1Legacy NDC, 3 package rows20201024_a2d586e2-352e-4fea-a95e-85b089f1dda3.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80905-00180905-001-03, 80905-001-02, 80905-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
LANOLIN7EV65EAW6HIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
METHYLPARABENA2I8C7HI9TIACT
PALM KERNEL ACID79P21R4317IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
COPOVIDONE K25-31D9C330MD8BIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
ISOBUTANEBXR49TP611IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PALMITIC ACID2V16EO95H1IACT
PERFLUOROPOLYMETHYLISOPROPYL ETHERX6324K3MBWIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANET75W9911L6IACT
BUTANE6LV4FOR43RIACT

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
a3f85945-4ab1-40bc-83aa-c157d3ba3427a2d586e2-352e-4fea-a95e-85b089f1dda32020-10-09WarningsExact identifier
spl id: a3f85945-4ab1-40bc-83aa-c157d3ba3427
spl set id: a2d586e2-352e-4fea-a95e-85b089f1dda3

Reported adverse events (FAERS/openFDA)#

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