Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b7b2f64e-27b4-4c71-95cf-78b37540f975
Route
TOPICAL
Published
Effective Date 2018-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Petrolatum Ceresin Ethylhexyl Palmitate Squalane Myristyl Myristate Castor Oil Myristyl Lactate Cetyl Alcohol Myristyl Laurate Myristyl Alcohol Butylated Hydroxytoluene Menthol, Unspecified Form .alpha.-tocopherol Octyldodecanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-15
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, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, 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, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, 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: 2026-02-15T12:04:52.686299 · Updated: 2026-03-14T23:05:57.575147