ITK BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene spray 
MAESA, 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 IngredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 10.0%Sunscreen
Octisalate 5.0%Sunscreen
Octocrylene 10.0%Sunscreen

Uses

Warnings

  • 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

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

Questions, Comments

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

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

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
ITK BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71899-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mg  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71899-065-011 in 1 CARTON08/01/2022
1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2022
Labeler - MAESA, LLC. (144282311)
Establishment
NameAddressID/FEIBusiness Operations
Emilia Resources, LLC079378421MANUFACTURE(71899-065)

Revised: 4/2022
Document Id: 7fa1bdec-1c60-4103-877d-519bdcea4bc1
Set id: 32a19bca-045a-4a06-a1bf-c50e282920b4
Version: 1
Effective Time: 20220411
 
MAESA, LLC.