FDA.reportPublic FDA data

ITK Broad spectrum SPF 30 Sunscreen

Manufacturer
MAESA, LLC. | Emilia Resources, LLC
Effective date
2022-04-11
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 30 Sunscreen
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Close eyes and mist onto clean, dry skin. Hold bottle 6 – 10 inches away from face, spraying evenly to ensure complete coverage. Do not spray into eyes. Use in well ventilated, but not windy 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 cance...

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:

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 10.0%Sunscreen
Octisalate 5.0%Sunscreen
Octocrylene 10.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

  • For external use only.
  • Flammable: Do not use near heat, flame, or while smoking.

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.
  • Close eyes and mist onto clean, dry skin.
  • Hold bottle 6 – 10 inches away from face, spraying evenly to ensure complete coverage.
  • Do not spray into eyes.
  • Use in well ventilated, but not windy 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

Alcohol Denat., Coco-Caprylate, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Acrylates/Octylacrylamide Copolymer, Water (Aqua/Eau), Phenyl Trimethicone, Tocopheryl Acetate, Bisabolol, 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 - 100 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

itk

SCAN ME

BROAD SPECTRUM
SPF 30 SUNSCREEN
SETTING MIST

sets makeup +
UVA/UVB protection +
blue light protection

3.3 FL. OZ. / 100 mL

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71899-065-012023-07-28C16284748780-10191ceaa-66b3-198a-e063-dbdaa90aec3eITK Broad spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71899-065-01ITK Broad spectrum SPF 30 Sunscreen100 mL in 1 BOTTLE, PUMPSPRAY1001
71899-065-01ITK Broad spectrum SPF 30 Sunscreen1 in 1 CARTONSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71899-065ITK BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) SPRAY [MAESA, LLC.]1Legacy NDC, 2 package rows20220801_32a19bca-045a-4a06-a1bf-c50e282920b4.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71899-06571899-065-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
ALCOHOL3K9958V90MIACT
Coco-Caprylate4828G836N6IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Diethylhexyl 2,6-NaphthalateI0DQJ7YGXMIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
WATER059QF0KO0RIACT
Phenyl TrimethiconeDR0K5NOJ4RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
Carnosine8HO6PVN24WIACT

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
7fa1bdec-1c60-4103-877d-519bdcea4bc132a19bca-045a-4a06-a1bf-c50e282920b42022-04-11WarningsExact identifier
spl id: 7fa1bdec-1c60-4103-877d-519bdcea4bc1
spl set id: 32a19bca-045a-4a06-a1bf-c50e282920b4

Reported adverse events (FAERS/openFDA)#

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