Topix Mineral Mattifying Tinted Sunscreen Lotion
FDA Label NDC 51326-137

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Topix Mineral Mattifying Tinted Sunscreen (NDC 51326-137). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • 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 of 15 or higher and other sunscreen measures including:
    • limit time in the sun, especially from 10a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Active Ingredient

Zinc Oxide 20.5%

Purpose

Sunscreen

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

For external use only.

Otc - When Using

  • When using this product keep out of eyes, rinse with water to remove.

Otc - Stop Use

  • Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.
  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Re-apply after swimming, excessive perspiring, or anytime after towel drying
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.

Inactive Ingredients

Ascorbic Acid, Biotin, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Ceramide NG, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone, Glycerin, Hexyl Laurate, Iron Oxides, Isododecane, Methyl Trimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, PEG-8 Methyl Ether Triethoxysilane, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Purified Water, Resveratrol, Silica Dimethyl Silylate, Silica, Stearic Acid, Titanium Dioxide, Tocopheryl Acetate, Ubiquinone (Co-Enzyme Q10).

Principal Display Panel - 54 G Bottle Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MULTI-TASKING

Mineral Mattifying
Tinted Sunscreen
SPF 50

Broad Spectrum SPF 50

Net wt. 1.9 oz. (54 g)

Available
Custom Branded
800.445.2595
[email protected]

Principal Display Panel (54 g Bottle Label)

Principal Display Panel (54 g Bottle Label)

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