ITK BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene spray

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

ACTIVE INGREDIENT

Active Ingredients	Purpose
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.

• 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, 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.

SPL UNCLASSIFIED SECTION

Dist. by Maesa LLC, New York, NY 10281

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

INGREDIENTS AND APPEARANCE

ITK BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71899-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mg  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 mg  in 100 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)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
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: 71899-065-01	1 in 1 CARTON	08/01/2022
1		100 mL in 1 BOTTLE, PUMP; 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(71899-065)