ITK Broad Spectrum SPF 50 Sunscreen Serum

Manufacturer
Emilia Resources, LLC
Effective date
2022-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:07:50

Label at a glance#

ProductITK Broad Spectrum SPF 50 Sunscreen Serum
Active ingredientZINC OXIDE
Label structure8 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...

Label contents#

Full prescribing information#

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.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.
  • Do not use in eye area. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 Stearate, 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:

SPL UNCLASSIFIED 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.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3Label4Label4

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-06643219-066-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d8dab10c-eebe-252f-e053-2a95a90a0f06d8dab10c-eebd-252f-e053-2a95a90a0f062022-02-25WarningsExact identifier
spl id: d8dab10c-eebe-252f-e053-2a95a90a0f06
spl set id: d8dab10c-eebd-252f-e053-2a95a90a0f06

Reported adverse events (FAERS/openFDA)#

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