drug facts - softlips vanilla

drug facts - softlips vanilla
SPL v4
SPL
SPL Set ID 56551008-a4e0-406f-8403-980d2e6b75a0
Route
topical
Published
Effective Date 2021-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (20 mg)
Inactive Ingredients
ceresin petrolatum ethylhexyl palmitate octyldodecanol squalane myristyl myristate castor oil myristyl lactate cetyl alcohol myristyl laurate myristyl alcohol butylated hydroxytoluene menthol, unspecified form .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-10-03
Purpose

Dimethicone - Skin protectant

Description

Dimethicone 2%

Medication Information

Warnings

For external use only

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

Dimethicone - Skin protectant

Directions
  • apply as needed
Inactive Ingredients

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

Description

Dimethicone 2%

Questions?

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

Active Ingredient

Dimethicone 2%

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

Warnings

For external use only

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

Dimethicone - Skin protectant

Directions
  • apply as needed
Inactive Ingredients (Inactive ingredients)

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

Questions?

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

Active Ingredient (Active ingredient)

Dimethicone 2%

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.

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: 2026-02-15T12:04:51.960206 · Updated: 2026-03-14T23:05:57.575147