Label: TIZO3- titanium dioxide, zinc oxide cream
- NDC Code(s): 58892-326-50
- Packager: Fallien Cosmeceuticals, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 1, 2024
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- Official Label (Printer Friendly)
- Active Ingredients:
- Purpose
-
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:
-
Directions:
Apply liberally 15 minutes before sun exposure.
Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying.
- At least every 2 hours. Children under 6 months: Ask a doctor
-
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 lime in the sun, especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Inactive Ingredients:
- Other Information:
- Principal Display Panel - 50 g Carton Label
- Principal Display Panel - 50 g Tube Label
-
INGREDIENTS AND APPEARANCE
TIZO3
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-326 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 85.4 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 40.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone 20 (UNII: H8YMB5QY0D) Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Dimethiconol (2000 CST) (UNII: T74O12AN6Y) Brown Iron Oxide (UNII: 1N032N7MFO) Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX) Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N) PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-326-50 1 in 1 CARTON 03/25/2015 1 44.4 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/21/2007 Labeler - Fallien Cosmeceuticals, LTD (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-326) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(58892-326) , PACK(58892-326)
