FDA Label for Body Defence Sunscreen Broad Spectrum Spf30

View Indications, Usage & Precautions

Body Defence Sunscreen Broad Spectrum Spf30 Product Label

The following document was submitted to the FDA by the labeler of this product Zelens Limited. 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.

Other



Drug Facts


Otc - Purpose



Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 5.0%Sunscreen
Octinoxate 7.5%Sunscreen
Octisalate 5.0%Sunscreen
Octocrylene 2.75%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


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.


Directions



  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor

Other Information



  • protect this product from excessive heat and direct sun
  • you may report a serious adverse reaction to this product to: Report Reaction, LLC
    PO Box 22 Plainsboro, NJ 08536-0222

Inactive Ingredients



Caprylic/Capric Triglyceride, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Dicaprylyl Ether, Olea Europaea (Olive) Fruit Oil, Sesamum Indicum (Sesame) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Polyester-7, Phospholipids, Perilla Frutescens Leaf Extract, Astragalus Membranaceus Root Extract, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Emblica Officinalis Fruit Extract, Echinacea Angustifolia Leaf Extract, Polypodium Leucotomos Root Extract, Rhodiola Rosea Root Extract, Silybum Marianum Extract, Ginkgo Biloba Leaf Extract, Pinus Strobus Bark Extract, Daucus Carota Sativa (Carrot) Root Extract, Glycine Soja (Soybean) Sterols, Glycolipids, Glycine Soja (Soybean) Oil, Zingiber Officinale Root Oil, Citrus Bergamia Melarosa Peel Oil Expressed, Citrus Limon Peel Oil, Citrus Aurantium Leaf Oil, Citrus Aurantifolia Peel Oil Distilled, Juniperus Mexicana Wood Oil, Coriandrum Sativum Seed Oil, Elettaria Cardamomum Seed Oil, Ferula Kokanica Resin Oil, Litsea Cubeba Fruit Oil, Myristica Fragrans Fruit Oil (Nutmeg), Salvia Sclarea Flower Oil, Thymus Vulgaris Oil, Tocopherol.


Principal Display Panel - 125 Ml Bottle Box



zelens
dr marko lens

Body Defence

SUNSCREEN
BROAD SPECTRUM SPF 30

Water Resistant (40 minutes)

Silky Oil

125 mL / 4.2 Fl. Oz.


* Please review the disclaimer below.