ITK Broad spectrum SPF 30 Sunscreen

ITK Broad spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

ITK Broad spectrum SPF 30 Sunscreen 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 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene 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 30 Sunscreen

Drug Facts:

Active Ingredients

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

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.

Warnings:

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

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.
• 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, C21-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Acrylates/Otylacrylamide 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.

Package Labeling:

ITK BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ACRYLIC ACID (UNII: J94PBK7X8S)
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
CARNOSINE (UNII: 8HO6PVN24W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-065-01	1 in 1 BOX	02/17/2022	12/31/2022
1		100 mL in 1 BOTTLE; 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	12/31/2022

Labeler - Emilia Resources, LLC (600076624)

Revised: 6/2023

Document Id: fe69f941-5aa0-516b-e053-6294a90a8334

34390-5

Set id: d8daa9e3-21a7-52c4-e053-2995a90a3887

Version: 2

Effective Time: 20230618