Trilipiderm Cream
FDA Label NDC 60892-602

12 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 60892-602). 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

Homosalate 10%, Ethylhexyl Methoxycinnamate 7.5%, Butyl Methoxydibenzoylmethane 3%, 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), I-Arginine, Ascorbic Acid (Vitamin C), Benzoic Acid, Cetearyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin D3), Crambe Abyssinica (Abyssinian) 0il, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Olea Europaea (Olive) Fruit Unsaponifiables, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Retinyl Palmitate (Vitamin A), Sodium Hyaluronate, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hydroxide, Squalane, Tocopheryl Acetate (Vitamin E)

Other Information

  • Protect this product from excessive heat and direct sun

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