FDA Label for Brickell Element Defense Moisturizer Spf-45

View Indications, Usage & Precautions

Brickell Element Defense Moisturizer Spf-45 Product Label

The following document was submitted to the FDA by the labeler of this product Brickell Brands Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:




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