FDA.reportPublic FDA data

Benchmarks Derma Shield

Manufacturer
Delta Kits Inc
Effective date
2023-10-02
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:56:21

Label at a glance#

ProductBenchmarks Derma Shield
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Dimethicone, 2.7%

OTC - PURPOSE SECTION

Purpose

Skin protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on:

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

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

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 120 oF

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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 6oz Aerosol USADerma Shield 6oz Aerosol USA

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
70557-002-022024-07-30C16284748780-1c7ccaba7-20eb-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-022021-08-30C16284748780-1c7ccaba7-20eb-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-022021-07-23C16284748780-1c7ccaba7-20eb-fd44-e053-dadaa90aa01bBenchmarks Derma Shield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70557-002-02Benchmarks Derma Shield170 g in 1 CANAEROSOL17010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70557-002BENCHMARKS DERMA SHIELD (DIMETHICONE) AEROSOL [DELTA KITS INC]10Legacy NDC, 1 package rows20231003_31806176-9d68-0066-e054-00144ff88e88.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
70557-00270557-002-02

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
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
DIMETHICONE92RU3N3Y1OACTIB

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
06bedbe1-e9e7-c8a2-e063-6294a90aba6931806176-9d68-0066-e054-00144ff88e882023-10-02WarningsExact identifier
spl id: 06bedbe1-e9e7-c8a2-e063-6294a90aba69
spl set id: 31806176-9d68-0066-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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