Softlips Peppermint Stick
FDA Label NDC 10742-8517

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Softlips Peppermint (NDC 10742-8517). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use and ask a doctor if, do not use, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

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

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

Do Not Use

on damaged or broken skin

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

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

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

Inactive Ingredients

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Questions?

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

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