FDA.reportPublic FDA data

ITK Broad Spectrum SPF 50 Sunscreen Serum

Manufacturer
MAESA, LLC. | Emilia Resources, LLC
Effective date
2022-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:19

Label at a glance#

ProductITK Broad Spectrum SPF 50 Sunscreen Serum
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Pump serum onto clean hands and work into a clean, dry face. Do not use in eye area. Use a water resistant sunscreen if swimming or sweating. Reapply 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 value of 15 o...

Storage and handling

Protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.
  • Do not use in eye area. Avoid contact with eyes. If contact occurs, flush 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, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Pump serum onto clean hands and work into a clean, dry face.
  • Do not use in eye area.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply 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 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua/Eau), Coco-Caprylate, Glyceryl Oleate Citrate, PEG-8 Stearate, Glyceryl Stearate, Tocopheryl Acetate, Polysorbate 20, Polyhydroxystearic Acid, Panthenol, Benzyl Alcohol, Cetearyl Alcohol, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Xanthan Gum, Sorbitan Oleate, Lauroyl Lysine, Sodium Phytate, Dehydroacetic Acid, Carnosine.

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product in this container from excessive heat and direct sun.

Questions, Comments

OTC - QUESTIONS SECTION

YOU MAY REPORT AN ADVERSE REACTION TO: ITK C/O REPORT REACTION LLC, PO BOX 22, PLAINSBORO, NJ 08536-0222.

SPL UNCLASSIFIED SECTION

Dist. by Maesa LLC,
New York, NY 10281

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

itk

SCAN ME

BROAD SPECTRUM
SPF 50 SUNSCREEN
SERUM

hydrates +
UVA/UVB protection +
blue light protection

2 FL. OZ. / 60 mL

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71899-066-012023-07-28C16284748780-10191ceaa-67ef-198a-e063-dbdaa90aec3eITK Broad Spectrum SPF 50 Sunscreen Serum, 60 ML

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71899-066-01ITK Broad Spectrum SPF 50 Sunscreen Serum60 mL in 1 TUBELIQUID601
71899-066-01ITK Broad Spectrum SPF 50 Sunscreen Serum1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71899-066ITK BROAD SPECTRUM SPF 50 SUNSCREEN SERUM (ZINC OXIDE) LIQUID [MAESA, LLC.]1Legacy NDC, 2 package rows20220801_85c741f8-b801-44d0-90f2-20e61d1c27ca.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71899-06671899-066-01

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
Zinc OxideSOI2LOH54ZACTIB
Carnosine8HO6PVN24WIACT
ALCOHOL3K9958V90MIACT
Coco-Caprylate4828G836N6IACT
GLYCERYL MONOOLEATE CITRATENLE5KIG74KIACT
PEG-8 Stearate2P9L47VI5EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Polysorbate 207T1F30V5YHIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PanthenolWV9CM0O67ZIACT
Benzyl AlcoholLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TriethoxycaprylylsilaneLDC331P08EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Xanthan GumTTV12P4NEEIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
Lauroyl Lysine113171Q70BIACT
PHYTATE SODIUM88496G1ERLIACT
Dehydroacetic Acid2KAG279R6RIACT

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
6f52126a-a3d8-485f-bd94-f93c55e367c885c741f8-b801-44d0-90f2-20e61d1c27ca2022-04-13WarningsExact identifier
spl id: 6f52126a-a3d8-485f-bd94-f93c55e367c8
spl set id: 85c741f8-b801-44d0-90f2-20e61d1c27ca

Reported adverse events (FAERS/openFDA)#

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