FDA.reportPublic FDA data

Cyberderm Simply Zinc Lite

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 21:20:06

Label at a glance#

ProductCyberderm Simply Zinc Lite
Active ingredientZINC OXIDE
Label structure15 sections

Storage and handling

Other information Protect this product from excessive heat and direct sun

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
  • 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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on broken skin

OTC - WHEN USING SECTION

When using this product avoid contact eyes. If contact occurs, rinse thoroughly with water.

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 swallowed, call a Poison Control Center or get medical help or right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children over 6 months of age

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

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

STORAGE AND HANDLING SECTION

Other information

  • Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Non-medicinal ingredients caprylic/capric triglyceride*, coco-caprylate/caprate*, polyglyceryl-3 polyricinoleate*, isostearic acid*, polylactic acid*, coconut alkanes*, sodium-phospho-magnesium silicate, carthamus tinctorius oleosomes*, water/eau, picea abies extract, propanediol*, titanium dioxide, stearic acid, alumina, cerium dioxide, silica, aluminum hydroxide, polyhydroxystearic acid.

OTC - QUESTIONS SECTION

Questions?

718-481-2628 Monday - Friday 9 am - 5 pm

SPL UNCLASSIFIED SECTION

Distributed by:

Cyberderm Laboratories Incorporated

650-1600 Carling Avenue

Ottawa, ON K1Z 1G3 Canada

Made in Canada

www.thesunscreencompany.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cyberderm

made with love by the sunscreen company™

Simply Zinc Lite

Transparent sunscreen lotion

made with 25% zinc oxide with Certified Organic Bio UVA

Ultra and Sheer Illuminating Tint

UVA/UVB Broad Spectrum SPF 50

helps prevent sunburn

100 mL (3.4 fl oz)

Simply Zinc LiteSimply Zinc Lite

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71644-008-012023-11-27C16284748780-10191ceaa-7177-198a-e063-dbdaa90aec3eCyberderm Simply Zinc Lite Sunscreen
71644-008-012023-07-28C16284748780-10191ceaa-7177-198a-e063-dbdaa90aec3eCyberderm Simply Zinc Lite Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-008CYBERDERM SIMPLY ZINC LITE (ZINC OXIDE) LOTION [CYBERDERM LABORATORIES INC.]3Legacy NDC20231128_a8620967-a95e-28a3-e053-2995a90a870b.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71644-00871644-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
PICEA ABIES FLOWER BUDWQZ50FAU2BIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CERIC OXIDE619G5K328YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCONUT ALKANES1E5KJY107TIACT
ZINC OXIDESOI2LOH54ZACTIM
ISOSTEARIC ACIDX33R8U0062IACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
POLYLACTIDE459TN2L5F5IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPANEDIOL5965N8W85TIACT

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
48326cc9-3066-d1aa-e063-6394a90a79dea8620967-a95e-28a3-e053-2995a90a870b2026-01-01WarningsExact identifier
spl set id: a8620967-a95e-28a3-e053-2995a90a870b

Reported adverse events (FAERS/openFDA)#

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