Brickell Element Defense Moisturizer Spf-45 Cream
FDA Label NDC 82247-234

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Brickell Brands Llc for the product Brickell Element Defense Moisturizer Spf-45 (NDC 82247-234). 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, active ingredients, purpose, uses:, warnings:, do not use, when using this product, 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

Drug Facts

Active Ingredients

Octocrylene 10.00%
Octisalate 5.00%
Zinc Oxide 5.00%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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 not intended for ingestion

Do Not Use

  • 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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every2 hourr
  • 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 broad spectrum protection SPF of 15 or higher, along with other sun protection measues including:
  • Limit time in the sun, especially between 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lantatus (Watermelon) Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, polyacrylamide, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Label (Label)

Label (Label)

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