Trilipiderm Cream
FDA Label NDC 60892-601

13 label sections · Submitted to the FDA by Trilipid Research Institute, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trilipid Research Institute, Llc for the product Trilipiderm (NDC 60892-601). 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, do not use, stop use and ask a doctor, 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

Butyl Methoxydibenzoylmethane 3%, Ethylhexyl Methoxycinnamate 7.5%, Homosalate 10%, Octocrylene 2.7%

Purpose

Sunscreen

Uses

  • Helps Prevent Sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For External Use Only

Do Not Use

on Damaged or Broken Skin

Stop Use And Ask A Doctor

If Rash Occurs

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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00 AM – 2:00 PM
  • Wear long sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Butylene Glycol, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Oil, Caprylyl Glycol, Ceteareth-20, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin B3), Crambe Abyssinica (Abyssinian) Oil, Dodecane, Gluconolactone, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Hexylene Glycol, Limnanthes Alba (Meadowfoam) Oil, Magnesium Aluminum Silicate, Meadowfoam Estolide, o-Cymen-5-ol, Olea Europeaea (Olive) Fruit Unsaponifiables, dl-Panthenol, Partum (Fragrance), Phenoxyethanol, Phytosterols, Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Oil, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum.

Other Information

  • Protect this product from excessive heat and direct sun

Other

Made in the USA * Distributed by:

Trilipid Research Institute LLC

Jackson, WY 83002

* Please review the disclaimer below.