Softlips Kit
FDA Label NDC 10742-7011

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 (NDC 10742-7011). 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 other, active ingredient, purpose, uses, warnings, do not use, when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Softlips Pearl

Drug Facts

Softlips Vanilla

Drug Facts

Active Ingredient

Octinoxate 7.5%

Octisalate 5%

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Octinoxate – Sunscreen

Octisalate - Sunscreen

Dimethicone – Skin protectant

Octinoxate – Sunscreen

Octisalate – Sunscreen

Oxybenzone - Sunscreen

Uses

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

Warnings

Skin Cancer/Skin Agent 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

Skin Cancer/Skin Agent 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

Do Not Use

on damaged or broken skin

on damaged or broken skin

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
    • rash occurs
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

Otc - 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage And Administration

  • 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
    • 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
    • protect this product from excessive heat and direct sun

Inactive Ingredients

lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide

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

Questions Or Comments?

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

Softlips.com

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

Softlips.com

When Using This Product

keep out of eyes. Rinse with water to remove.

* Please review the disclaimer below.