ITK BROAD SPECTRUM SPF 50 SUNSCREEN SERUM- zinc oxide liquid

ITK Broad Spectrum SPF 50 Sunscreen Serum by

Drug Labeling and Warnings

ITK Broad Spectrum SPF 50 Sunscreen Serum by is a Otc medication manufactured, distributed, or labeled by MAESA, LLC., Emilia Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredients

Zinc Oxide 24.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• For external use only.

• 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.

• Stop use and ask a doctor if rash occurs.

• 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.
• 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

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.

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.

SPL UNCLASSIFIED SECTION

Dist. by Maesa LLC,
New York, NY 10281

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

INGREDIENTS AND APPEARANCE

ITK BROAD SPECTRUM SPF 50 SUNSCREEN SERUM 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71899-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	24.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Carnosine (UNII: 8HO6PVN24W)
ALCOHOL (UNII: 3K9958V90M)
Coco-Caprylate (UNII: 4828G836N6)
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)
PEG-8 Stearate (UNII: 2P9L47VI5E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Polysorbate 20 (UNII: 7T1F30V5YH)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Panthenol (UNII: WV9CM0O67Z)
Benzyl Alcohol (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Triethoxycaprylylsilane (UNII: LDC331P08E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Xanthan Gum (UNII: TTV12P4NEE)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
Lauroyl Lysine (UNII: 113171Q70B)
PHYTATE SODIUM (UNII: 88496G1ERL)
Dehydroacetic Acid (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71899-066-01	1 in 1 CARTON	08/01/2022
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2022

Labeler - MAESA, LLC. (144282311)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Resources, LLC		079378421	MANUFACTURE(71899-066)