Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 4a133e73-e51b-4f04-91de-dc8c4d4dba30
Route
TOPICAL
Published
Effective Date 2019-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Ceresin Petrolatum Ethylhexyl Palmitate Squalane Octyldodecanol Myristyl Myristate Castor Oil Myristyl Lactate Cetyl Alcohol Myristyl Laurate Myristyl Alcohol Ammonium Glycyrrhizate Butylated Hydroxytoluene Levomenthol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-30
Description

Dimethicone 2%

Purpose

Dimethicone - Skin protectant

Medication Information

Purpose

Dimethicone - Skin protectant

Description

Dimethicone 2%

Uses
  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Warnings

For external use only

Directions
  • apply as needed
Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

Active Ingredients

Dimethicone 2%

Inactive Ingredients

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, flavor, myristyl laurate, myristyl alcohol, ammonium glcyrrhizate, BHT, menthol, tocopheryl acetatate [vitamin E]

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.

Package/label Principal Display Panel

Structured Label Content

Uses
  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Purpose

Dimethicone - Skin protectant

Warnings

For external use only

Directions
  • apply as needed
Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

Active Ingredients (Active ingredients)

Dimethicone 2%

Inactive Ingredients (Inactive ingredients)

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, flavor, myristyl laurate, myristyl alcohol, ammonium glcyrrhizate, BHT, menthol, tocopheryl acetatate [vitamin E]

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

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:51.954016 · Updated: 2026-03-14T23:05:57.575147