benchmarks derma shield

benchmarks derma shield
SPL v9
SPL
SPL Set ID 31806176-9d6d-0066-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (2.7 g)
Inactive Ingredients
propylparaben polyoxyl 20 cetostearyl ether citric acid monohydrate diazolidinyl urea glycerin hydroxyethyl cellulose (4000 mpa.s at 1%) methylparaben palm kernel acid propylene glycol sodium benzoate copovidone k25-31 edetate sodium .alpha.-tocopherol acetate trolamine aloe vera leaf water cetyl alcohol isobutane isopropyl myristate palmitic acid perfluoropolymethylisopropyl ether potassium sorbate propane butane lanolin

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-04-27
Description

Active ingredient Dimethicone, 2.7%

Medication Information

Warnings and Precautions

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
Active Ingredient

Active ingredient

Dimethicone, 2.7%

Indications and Usage

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
Dosage and Administration

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
Description

Active ingredient Dimethicone, 2.7%

Section 50565-1

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns
  • Keep out of reach of children
Section 51727-6

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

Section 51945-4

Section 55105-1

Purpose

Skin protectant

Structured Label Content

Warnings and Precautions (34071-1)

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
Active Ingredient (55106-9)

Active ingredient

Dimethicone, 2.7%

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Section 50565-1 (50565-1)

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns
  • Keep out of reach of children
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin protectant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:18.350803 · Updated: 2026-03-14T23:01:21.342577