Label: ITK BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71899-065-01 - Packager: MAESA, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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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.
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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
- Other Information
- Questions, Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
ITK BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene sprayProduct 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)
