FDA.reportPublic FDA data

Ultimate Skin Protectant Derma Shield

Manufacturer
Fleet Laboratories LTD
Effective date
2019-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:47

Label at a glance#

ProductUltimate Skin Protectant Derma Shield
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Dimethicone 2.7% Skin Protectant

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up again within a few days

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°F

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myristate, 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 Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate,Citric Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benchmark's

DermaShield

The Ultimate Skin Protectant

Net Weight 17 oz(1lb 1 oz) (482g)

17 oz -6 US17 oz -6 US

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
70233-010-012021-01-29C16284748780-1ba0f9c33-3dce-a910-e053-dadaa90a0b85Ultimate Skin Protectant Derma Shield
70233-010-022021-01-29C16284748780-1ba0f9c33-3dce-a910-e053-dadaa90a0b85Ultimate Skin Protectant Derma Shield
70233-010-032021-01-29C16284748780-1ba0f9c33-3dce-a910-e053-dadaa90a0b85Ultimate Skin Protectant Derma Shield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70233-010-01Ultimate Skin Protectant Derma Shield482 g in 1 CANAEROSOL4821
70233-010-02Ultimate Skin Protectant Derma Shield170 g in 1 CANAEROSOL1701
70233-010-03Ultimate Skin Protectant Derma Shield57 g in 1 CANAEROSOL571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70233-010ULTIMATE SKIN PROTECTANT DERMA SHIELD (DIMETHICONE) AEROSOL [FLEET LABORATORIES LTD]1Legacy NDC, 3 package rows20191015_941cf550-4e0a-0b58-e053-2995a90a64a9.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70233-01070233-010-01, 70233-010-02, 70233-010-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOBUTANEBXR49TP611IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
EDETATE SODIUMMP1J8420LUIACT
LANOLIN7EV65EAW6HIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PALM KERNEL ACID79P21R4317IACT
COPOVIDONE K25-31D9C330MD8BIACT
DIMETHICONE92RU3N3Y1OACTIB
PROPYLPARABENZ8IX2SC1OHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
PALMITIC ACID2V16EO95H1IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
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
941cf550-4e0b-0b58-e053-2995a90a64a9941cf550-4e0a-0b58-e053-2995a90a64a92019-10-04WarningsExact identifier
spl id: 941cf550-4e0b-0b58-e053-2995a90a64a9
spl set id: 941cf550-4e0a-0b58-e053-2995a90a64a9

Reported adverse events (FAERS/openFDA)#

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