FDA.reportPublic FDA data

Eleven Unrivaled Sun Serum

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 Unrivaled Sun Serum
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Polylactic Acid, Coconut Alkanes, Coco-Caprylate/Caprate, Carthamus Tinctorius Oleasomes, Aqua, Opuntia Ficus-Incida Stem Extract (Prickly Pear), Cellulose, Sorbitan Oleate

OTHER SAFETY INFORMATION

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 value of SPF 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, 660-1600 CARLING AVE, OTTAWA ON K1Z 1G3

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELEVEN BY VENUS

UNRIVALED SUN SERUM

SPF 35

100% Sheer Mineral Broad Spectrum

25% Zinc Oxide

Sunscreen Serum

UVA/UVB Protection

30 ML/1 FL. OZ.

Eleven-Secondary-SerumEleven-Secondary-Serum

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71644-006-302023-11-27C16284748780-10191ceaa-6510-198a-e063-dbdaa90aec3eEleven Unrivaled Sun Serum SPF 35
71644-006-302023-07-28C16284748780-10191ceaa-6510-198a-e063-dbdaa90aec3eEleven Unrivaled Sun Serum SPF 35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-006ELEVEN UNRIVALED SUN SERUM (ZINC OXIDE) LIQUID [CYBERDERM LABORATORIES INC.]3Legacy NDC20231128_9d110ec2-8401-0460-e053-2995a90a683c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-00671644-006-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
COCONUT ALKANES1E5KJY107TIACT
POWDERED CELLULOSESMD1X3XO9MIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYLACTIDE459TN2L5F5IACT
WATER059QF0KO0RIACT
OPUNTIA FICUS-INDICA STEMMUD8892KHLIACT

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
48326a3c-d9e9-ceee-e063-6394a90afe119d110ec2-8401-0460-e053-2995a90a683c2026-01-01WarningsExact identifier
spl set id: 9d110ec2-8401-0460-e053-2995a90a683c

Reported adverse events (FAERS/openFDA)#

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