Body Defence Sunscreen Broad Spectrum Spf30
FDA Label NDC 63712-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zelens Limited for the product Body Defence Sunscreen Broad Spectrum Spf30 (NDC 63712-201). 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 other, otc - purpose, uses, 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.

Label Section Quick Index

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.

Principal Display Panel (125 mL Bottle Box)

Principal Display Panel (125 mL Bottle Box)

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