ITK Broad Spectrum SPF 50 Sunscreen Serum

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 Emilia Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ITK BROAD SPECTRUM SPF 50 SUNSCREEN SERUM- zinc oxide liquid 
Emilia Resources, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ITK Broad Spectrum SPF 50 Sunscreen Serum

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 Stearate, 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.

Package Labeling:

ITK BROAD SPECTRUM SPF 50 SUNSCREEN SERUM 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	245 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
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)
CARNOSINE (UNII: 8HO6PVN24W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-066-01	1 in 1 BOX	02/17/2022
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	02/17/2022

Labeler - Emilia Resources, LLC (600076624)

Revised: 2/2022

Document Id: d8dab10c-eebe-252f-e053-2a95a90a0f06

34390-5

Set id: d8dab10c-eebd-252f-e053-2a95a90a0f06

Version: 1

Effective Time: 20220225