Itk Broad Spectrum Spf 50 Sunscreen Serum, 60 Ml

Itk Broad Spectrum Spf 50 Sunscreen Serum, 60 Ml
SPL v1
SPL
SPL Set ID 85c741f8-b801-44d0-90f2-20e61d1c27ca
Route
TOPICAL
Published
Effective Date 2022-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.5 mg)
Inactive Ingredients
Carnosine Alcohol Coco-caprylate Glyceryl Monooleate Citrate Peg-8 Stearate Glyceryl Monostearate .alpha.-tocopherol Acetate Polysorbate 20 Polyhydroxystearic Acid (2300 Mw) Panthenol Benzyl Alcohol Cetostearyl Alcohol Triethoxycaprylylsilane Medium-chain Triglycerides Xanthan Gum Sorbitan Monooleate Lauroyl Lysine Phytate Sodium Dehydroacetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-08-01

Description

Drug Facts:

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts:

Uses
  • Helps prevent sunburn.
Section 42229-5

Drug Facts:

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs.
Section 50570-1
  • 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.
Warnings
  • For external use only.
Directions
  • 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.
Other Information
  • Protect this product in this container from excessive heat and direct sun.
Active Ingredients

Zinc Oxide 24.5%

Questions, Comments

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

Inactive Ingredients

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.

Principal Display Panel 60 Ml Tube Carton

itk

SCAN ME

BROAD SPECTRUM

SPF 50 SUNSCREEN

SERUM

hydrates +

UVA/UVB protection +

blue light protection

2 FL. OZ. / 60 mL


Structured Label Content

Uses
  • Helps prevent sunburn.
Section 42229-5 (42229-5)

Drug Facts:

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs.
Section 50570-1 (50570-1)
  • 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.
Purpose

Sunscreen

Warnings
  • For external use only.
Directions
  • 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.
Other Information
  • Protect this product in this container from excessive heat and direct sun.
Active Ingredients

Zinc Oxide 24.5%

Questions, Comments

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

Inactive Ingredients

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.

Principal Display Panel 60 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton)

itk

SCAN ME

BROAD SPECTRUM

SPF 50 SUNSCREEN

SERUM

hydrates +

UVA/UVB protection +

blue light protection

2 FL. OZ. / 60 mL


Advanced Ingredient Data


Raw Label Data

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