FDA.reportPublic FDA data

Eleven Perfect Form Tinted Lip Balm

Manufacturer
Cyberderm Laboratories inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:20:06

Label at a glance#

ProductEleven Perfect Form Tinted Lip Balm Game Day
Active ingredientZINC OXIDE
Label structure11 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-sleev...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 20%

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 15 minutes before sun exposure. Reapply at least every 2 hours.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable Oil, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Polyhydroxystearic Acid, Behenyl Behenate, Polyglyceryl-10 Stearate, Sodium Stearoyl Lactylate, Glyceryl Isostearate, Tocopherol. May contain Red 7, Aluminum Hydroxide, BetaVulgaris (Beet) Root Extract, Citric Acid, Ascorbic Acid, Maltodextrin, Monoammonium Glycyrrhizinate

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?
718-481-2628.

SPL UNCLASSIFIED SECTION

MADE IN COLLABORATION WITH THE SUNSCREEN COMPANY™

DIST. BY CYBERDERM LABORATORIES

650-1600 CARLING AVE

OTTAWA ON CANADA K1Z 1G3

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELEVEN

BY VENUS WILLIAMS
PERFECT FORM TINTED LIP BALM
SPF 15

100% Mineral Broad Spectrum
GAME DAY

20% Zinc Oxide

Sunscreen Lip Balm

UVA/UVB Protection
10ML / 0.34 FL. OZ.

Cyberderm Eleven-LB-GameDay-02-21Cyberderm Eleven-LB-GameDay-02-21

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71644-012-102023-11-27C16284748780-10191ceaa-6d1a-198a-e063-dbdaa90aec3eEleven Tinted Lip Balm Game Day
71644-012-102023-07-28C16284748780-10191ceaa-6d1a-198a-e063-dbdaa90aec3eEleven Tinted Lip Balm Game Day

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-012ELEVEN PERFECT FORM TINTED LIP BALM GAME DAY (ZINC OXIDE) CREAM [CYBERDERM LABORATORIES INC.]4Legacy NDC20231128_a888c4ba-053e-1843-e053-2a95a90a76fd.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-01271644-012-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BEETN487KM8COKIACT
D&C RED NO. 7ECW0LZ41X8IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
MALTODEXTRIN7CVR7L4A2DIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SHEA BUTTERK49155WL9YIACT
MORELLA CERIFERA FRUIT WAXL41B20QT0MIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
CANDELILLA WAXWL0328HX19IACT
LAURYL LAURATEGPW77G0937IACT
BEHENYL BEHENATEK8NU647RJ0IACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
ZINC OXIDESOI2LOH54ZACTIM
CORN OIL8470G57WFMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
48326f62-4954-fcd3-e063-6294a90a9fefa888c4ba-053e-1843-e053-2a95a90a76fd2026-01-01WarningsExact identifier
spl set id: a888c4ba-053e-1843-e053-2a95a90a76fd

Reported adverse events (FAERS/openFDA)#

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