FDA.reportPublic FDA data

BODY DEFENCE SUNSCREEN Broad Spectrum SPF30

Manufacturer
ZELENS Limited | Originitalia
Effective date
2019-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:25

Label at a glance#

ProductBODY DEFENCE SUNSCREEN Broad Spectrum SPF30
Active ingredientOCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure8 sections

Indications and 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

Dosage and administration

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, ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63712-201-012022-01-28C16284748780-1d6a99b39-b969-a426-e053-dadaa90af4c2BODY DEFENCE SUNSCREEN Broad Spectrum SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63712-201-01BODY DEFENCE SUNSCREEN Broad Spectrum SPF30125 mL in 1 BOTTLE, PUMPOIL1252
63712-201-01BODY DEFENCE SUNSCREEN Broad Spectrum SPF301 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63712-201BODY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 (OCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) OIL [ZELENS LIMITED]2Legacy NDC, 2 package rows20191106_75d985ca-971d-4529-a9f0-685c8879b942.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63712-20163712-201-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DICAPRYLYL ETHER77JZM5516ZIACT
OLIVE OIL6UYK2W1W1EIACT
SESAME OILQX10HYY4QVIACT
GRAPE SEED OIL930MLC8XGGIACT
POLYESTER-70841698D2FIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PERILLA FRUTESCENS LEAFT4L5881Y68IACT
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFIACT
TURMERIC856YO1Z64FIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CENTELLA ASIATICA7M867G6T1UIACT
ECHINACEA ANGUSTIFOLIA LEAFFS7G8S6PJ8IACT
GINKGO19FUJ2C58TIACT
PINUS STROBUS BARK8PJ4761097IACT
PHYLLANTHUS EMBLICA FRUITYLX4CW2576IACT
PHLEBODIUM AUREUM ROOTVPS45WBU8UIACT
SEDUM ROSEUM ROOT3S5ITS5ULNIACT
MILK THISTLEU946SH95EEIACT
CARROTL56Z1JK48BIACT
SOY STEROLPL360EPO9JIACT
SOYBEAN OIL241ATL177AIACT
GINGERC5529G5JPQIACT
BERGAMOT OIL39W1PKE3JIIACT
LEMON OILI9GRO824LLIACT
BITTER ORANGE OIL9TLV70SV6IIACT
LIME OILUZH29XGA8GIACT
CEDRUS ATLANTICA BARK OILZX5QRE4U60IACT
CORIANDER OIL7626GC95E5IACT
CARDAMOM OILJM0KJ091HZIACT
GALBANUM OIL211UF7M8N1IACT
LITSEA OIL2XIW34BN6OIACT
NUTMEG OILZ1CLM48948IACT
CLARY SAGE OIL87L0D4U3M0IACT
THYME OIL2UK410MY6BIACT
TOCOPHEROLR0ZB2556P8IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96a4f339-5504-3dda-e053-2a95a90aed0375d985ca-971d-4529-a9f0-685c8879b9422019-11-05WarningsExact identifier
spl id: 96a4f339-5504-3dda-e053-2a95a90aed03
spl set id: 75d985ca-971d-4529-a9f0-685c8879b942

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.