Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 56869b64-11ee-4df6-8102-ce5818e0116e
Route
TOPICAL
Published
Effective Date 2011-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (15 mg)
Inactive Ingredients
Glutamic Acid Threonine Chlorphenesin Lysine Polyglyceryl-4 Isostearate Glycine Serine Hexyl Laurate Histidine Alanine Safflower Oil Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Butylene Glycol Silicon Dioxide Hyaluronate Sodium Isoleucine Tyrosine Valine Kukui Nut Oil Aloe Vera Leaf Calcium Pantothenate Maltodextrin Niacinamide Pyridoxine Hydrochloride Sodium Ascorbyl Phosphate .alpha.-tocopherol Acetate, Dl- Arginine Carthamus Tinctorius Seed Oleosomes Caprylyl Glycol Dicaprylyl Carbonate Phenoxyethanol Propylene Glycol Propylheptyl Caprylate Water Leucine Phenylalanine Sodium Chloride Proline Cetyl Alcohol Aspartic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-09-01
Description

Dimethicone 1.5%

Purpose

Skin Protectant

Medication Information

Purpose
  • Skin Protectant

Description

Dimethicone 1.5%

Uses



  • For the treatment and/or prevention of diaper rash
  • Temporarily protects and helps relieve chapped or cracked skin

Warnings
  • For external use only
  • Protect from freezing. Avoid excessive heat.

Directions
  • Apply liberally as needed
Label (4g)

NDC 68599-0204-1

Thera

Moisturizing Body Shield

Net Contents 4 g (0.14 oz)

MFR# 53-MS4G

Label (4 Oz)

NDC 68599-0204-4

Thera

Moisturizing Body Shield

Net Contents 4 fl oz (118 mL)

MFR# 53-MS4

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient
  • Dimethicone 1.5%

Inactive Ingredients

Inactive ingredients

Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aloe

Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene

Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol,

Carthamus Tinctorius (Safflower) Oleosomes, Carthamus

Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl

Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,

Chlorphenesin, Dicaprylyl Carbonate, Dimethicone

Crosspolymer, Fragrance, Glutamic Acid, Glycine, Hexyl

Laurate, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin,

Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine,

Polyglyceryl-4 Isostearate, Proline, Propylene Glycol,

Propylheptyl Caprylate, Pyridoxine HCL (Vitamin B6), Serine,

Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium

Chloride, Sodium Hyaluronate, Sodium Starch

Octenylsuccinate, Threonine, Tocopheryl Acetate (Vitamin

E), Tyrosine, Valine, Water

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor If
  • condition worsens

  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses



  • For the treatment and/or prevention of diaper rash
  • Temporarily protects and helps relieve chapped or cracked skin

Purpose
  • Skin Protectant

Warnings
  • For external use only
  • Protect from freezing. Avoid excessive heat.

Directions
  • Apply liberally as needed
Label (4g)

NDC 68599-0204-1

Thera

Moisturizing Body Shield

Net Contents 4 g (0.14 oz)

MFR# 53-MS4G

Label (4 Oz) (Label (4 oz))

NDC 68599-0204-4

Thera

Moisturizing Body Shield

Net Contents 4 fl oz (118 mL)

MFR# 53-MS4

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)
  • Dimethicone 1.5%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aloe

Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene

Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol,

Carthamus Tinctorius (Safflower) Oleosomes, Carthamus

Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl

Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,

Chlorphenesin, Dicaprylyl Carbonate, Dimethicone

Crosspolymer, Fragrance, Glutamic Acid, Glycine, Hexyl

Laurate, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin,

Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine,

Polyglyceryl-4 Isostearate, Proline, Propylene Glycol,

Propylheptyl Caprylate, Pyridoxine HCL (Vitamin B6), Serine,

Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium

Chloride, Sodium Hyaluronate, Sodium Starch

Octenylsuccinate, Threonine, Tocopheryl Acetate (Vitamin

E), Tyrosine, Valine, Water

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens

  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)
  • If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.372664 · Updated: 2026-03-14T23:03:06.131630