Label: SOLAR PROTECTION FORMULA TIZO SPF 35 SUNSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58892-318-01 - Packager: Fallien Cosmeceuticals, LTD.
- Category: HUMAN OTC DRUG LABEL
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 December 18, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose
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Uses:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings:
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Directions:
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
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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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Other Information:
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Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Manufactured exclusively for
Fallien, Ltd.
West Norriton PA 19403
Made in USA - Principal Display Panel – SPF 35 100g Carton Label
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INGREDIENTS AND APPEARANCE
SOLAR PROTECTION FORMULA TIZO SPF 35 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-318 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Caprylhydroxamic Acid (UNII: UPY805K99W) Caprylyl Glycol (UNII: 00YIU5438U) Cetyl PEG/PPG-10/1 Dimethicone (HLB 5) (UNII: 035JKJ76MT) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone 100 (UNII: RO266O364U) Dimethicone/Diene Dimethicone Crosspolymer (UNII: RSA9I561OK) Edetate Disodium (UNII: 7FLD91C86K) Methicone (20 cst) (UNII: 6777U11MKT) Microcrystalline Wax (UNII: XOF597Q3KY) PEG-10 Dimethicone (600 cst) (UNII: 8PR7V1SVM0) PEG-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Polysorbate 20 (UNII: 7T1F30V5YH) Sodium Chloride (UNII: 451W47IQ8X) Stearyl Dimethicone (400 MPA.S AT 50C) (UNII: R327X197HY) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Trolamine (UNII: 9O3K93S3TK) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-318-01 1 in 1 CARTON 1 100 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/02/2012 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-318) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE(58892-318)