Drug Facts - Mentholatum Medicated Lip Balm

Drug Facts - Mentholatum Medicated Lip Balm
SPL v4
SPL
SPL Set ID f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1
Route
TOPICAL
Published
Effective Date 2016-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (10 mg) Octinoxate (75 mg) Octisalate (50 mg)
Inactive Ingredients
Lanolin Menthol, Unspecified Form Mineral Oil Ceresin Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-01
Description

Dimethicone 1% Octinoxate 7.5% Octisalate 5%

Purpose

Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen

Medication Information

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Description

Dimethicone 1% Octinoxate 7.5% Octisalate 5%

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Other information

  • protect this product from excessive heat and direct sun
Do Not Use

on damaged or broken skin

Questions?

Toll free 1-877-636-2677

MON-FRI 9 AM to 5 PM (EST)

Active Ingredients

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Inactive Ingredients

fragrance, lanolin, menthol, mineral oil, ozokerite, petrolatum

Principal Display Panel
When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If
  • rash occurs
  • 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
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Other information

  • protect this product from excessive heat and direct sun
Do Not Use (Do not use)

on damaged or broken skin

Questions?

Toll free 1-877-636-2677

MON-FRI 9 AM to 5 PM (EST)

Active Ingredients (Active ingredients)

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

fragrance, lanolin, menthol, mineral oil, ozokerite, petrolatum

Principal Display Panel
When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
  • 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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:52.748371 · Updated: 2026-03-14T23:05:59.331876