Itk Broad Spectrum Spf 30 Sunscreen
FDA Label NDC 71899-065

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Maesa, Llc. for the product Itk Broad Spectrum Spf 30 Sunscreen (NDC 71899-065). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts:

Dist. by Maesa LLC, New York, NY 10281

Otc - Purpose

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

Uses

  • Helps prevent sunburn.

Warnings

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

Otc - Do Not Use

  • 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

  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

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

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

Questions, Comments

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

Principal Display Panel - 100 Ml Bottle Carton

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)

* Please review the disclaimer below.