1. Home
  2. Labeler Index
  3. Fallien Cosmeceuticals, Ltd
  4. 58892-101
  5. Label Information: Tizo Photoceutical Am Replenish - Tinted

FDA Label for Tizo Photoceutical Am Replenish - Tinted

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. USES:
    4. WARNINGS:
    5. DIRECTIONS:
    6. INACTIVE INGREDIENTS:
    7. OTHER INFORMATION:
    8. PRINCIPAL DISPLAY PANEL – CARTON LABEL
    9. PRINCIPAL DISPLAY PANEL – TUBE LABEL

Tizo Photoceutical Am Replenish - Tinted Product Label

The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



Zinc Oxide 16%


Purpose:



Sunscreen


Uses:



Helps prevents 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:



For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. 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.
  • Use a water resistant product if swimming or sweating.
  • Reapply:
    • - 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 time in the sun, especially from 10 a.m. - 2 p.m.
      • - Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:



Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer


Other Information:



  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.

Principal Display Panel – Carton Label



AM
REPLENISH

Lightly Tinted
SPF 40

TIZO®

PHOTOCEUTICAL®

Enhances, protects &
neutralizes free radicals

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY®

Broad Spectrum SPF 40

Net Wt. 1.75 oz/50 g


Principal Display Panel – Tube Label



TIZO®

PHOTOCEUTICAL

AM
REPLENISH

Lightly Tinted

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY®

SPF 40
Broad Spectrum

1.75 Fl. Oz/50 mL


* Please review the disclaimer below.