Eleven On the Defense

Manufacturer
Cyberderm Laboratories Inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:20:05

Label at a glance#

ProductEleven On the Defense Sunscreen
Active ingredientZINC OXIDE
Label structure15 sections

Storage and handling

Other information Protect this product from excessive heat and direct sun May stain some fabrics 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 value 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-sleeved...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 25%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn.

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally and evenly to face and neck 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT SECTION

Inactive ingredients Aqua, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Polylactic Acid, Propanediol, Saccharomyces Ferment, Hydrogenated Sunflower Seed Oil Polyglyceryl-3 Esters, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Sorbitan Oleate, Acacia Senegal Gum, Cellulose, Caprylhydroxamic Acid, 1,2-Hexanediol, Xanthan Gum.

STORAGE AND HANDLING SECTION

Other information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

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 value 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-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

OTC - QUESTIONS SECTION

Questions or Comments?

Call 718-481-2628

SPL UNCLASSIFIED SECTION

MADE IN COLLABORATION WITH THE SUNSCREEN COMPANY™

DIST. BY: CYBERDERM LABORATORIES,

650-1600 CARLING AVENUE

OTTAWA, ON K1Z 1G3

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELEVEN BY VENUS

ON-THE-DEFENSE SUNSCREEN

SPF 30

100% Sheer Mineral

Broad Spectrum

25% Zinc Oxide Sunscreen Lotion

UVA/UVB Protection

50 ml (1.7 FL. OZ.)

Eleven-Secondary-Lotion-121819Eleven-Secondary-Lotion-121819

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-005ELEVEN ON THE DEFENSE SUNSCREEN (ZINC OXIDE) LOTION [CYBERDERM LABORATORIES INC.]3Legacy NDC20231128_9d0cde1a-537e-96d4-e053-2a95a90abdcf.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-00571644-005-50, 71644-005-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
48325291-04c2-f55e-e063-6294a90ad23d9d0cde1a-537e-96d4-e053-2a95a90abdcf2026-01-01WarningsExact identifier
spl set id: 9d0cde1a-537e-96d4-e053-2a95a90abdcf

Reported adverse events (FAERS/openFDA)#

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