Trienelle Skincare Daily Renewal Creme
FDA Label NDC 50972-736

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newmarket Health Products Llc for the product Trienelle Skincare Daily Renewal Creme (NDC 50972-736). 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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts


Active Ingredient

Octinoxate 5.0%

Oxybenzone 4.5%

Avobenzone 3.0%

Otc - Purpose

Purpose

Sunscreen

Indications & Usage

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

  • Apply cream evenly twice daily to the face, neck, and other exposed areas before exposure to sun.
  • Children under 6 months of age: 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 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 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating. 

Inactive Ingredient

Inactive Ingredients

Water, Glycerin, C12-15 Alkyl Benzoate, Phenyl Trimethicone, Cyclomethicone, Tocotrienol, Dimethicone, PEG-100 Stearate, Glyceryl Stearate, Tocopherol, Cetearyl Alcohol, Cetyl Alcohol, Vaccinium Myrtillus Fruit and Leaf Extract, Chlorella Vulgaris Extract, Ganoderma Lucidum (Mushroom) Stem Extract, Trametes Versicolor Extract, Saccharum Officinarum Extract, Acer Sacharinum Extract, Citrus Aurantium Dulcis Fruit Extract, Citrus Limon Extract, Palmitoyl Pentapeptide, Superoxide Dismutase, Stevia Rebaudiana Extract, Foeniculum Vulgare Extract, Hydrolyzed Algin, Applephenone, Salix Alba (Bark) Extract, Colostrum, Melatonin, Squalene, Elaies Guineensis Oil, Phytosterols, Sea Water, Phospholipids, Butylene Glycol, Triacontanyl PVP, Phenoxyethenol, Xanthan Gum, Ceteareth-20, Carbomer, Polysorbate-20, Methylparaben, Butylparaben, Propylparaben, Ethylparaben, Tetrasodium EDTA, Triethanolamine

Other Safety Information

Other Information

  • Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect the product in this container from excessive heat and direct sun.

Otc - Questions

Distributed by

Trienelle Skincare, Inc.

702 Cathedral St.

Baltimore, MD 21201

1-800-539-5195

www.trienelle.com

Package Label.Principal Display Panel

Trienelle Skincare

Daily Renewal Creme

WITH TOCALLURE RESTORATION COMPLEX

Broad Spectrum SPF 15

Formulated to:

Visibly rejuvenate your skin to help reduce the signs of aging

Net. 50 ml (1.7 fl oz)

Daily Renewal Box (Dailyrenewal50 Box)

Daily Renewal Box (Dailyrenewal50 Box)

* Please review the disclaimer below.