FDA.reportPublic FDA data

ITK Broad spectrum SPF 30 Sunscreen

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 22:07:49

Label at a glance#

ProductITK Broad spectrum SPF 30 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 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 cancer ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 10.0%

Purpose

OTC - PURPOSE SECTION

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.

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.
  • 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, C21-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Acrylates/Otylacrylamide Copolymer, Water (Aqua/Eau), Phenyl Trimethicone, Tocopheryl Acetate, Bisabolol, 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

LabelLabelLabel2Label2

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
43219-06543219-065-01

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
ALCOHOL3K9958V90MIACT
COCO-CAPRYLATE4828G836N6IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
ACRYLIC ACIDJ94PBK7X8SIACT
WATER059QF0KO0RIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
CARNOSINE8HO6PVN24WIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
fe69f941-5aa0-516b-e053-6294a90a8334d8daa9e3-21a7-52c4-e053-2995a90a38872023-06-18WarningsExact identifier
spl set id: d8daa9e3-21a7-52c4-e053-2995a90a3887

Reported adverse events (FAERS/openFDA)#

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