Alex Md Phd Tinted Mineral Sunscreen Cream
FDA Label NDC 78709-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physician Laboratories Inc for the product Alex Md Phd Tinted Mineral Sunscreen (NDC 78709-002). 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 active ingredient, purpose, uses, warnings, directions, inactive igredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide, 20.2%
Titanium Dioxide, 6.8%

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

Warnings

  • For external use only
  • Do not use ondamaged or broken skin.
  • When using this productkeep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctorif rash occurs.
  • Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
  • After 80 minutes of swimmingor 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 of 15 or higher and other sun protection measures including:
       •Limit time in the sun, especially from 10am–2pm.
       •Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Igredients

Cyclopentasiloxane, Water/Aqua/Eau, Coco-Caprylate /Caprate, Isononyl Isononanoate, Polyglyceryl-3 Polydimethylsiloxyethyl
Dimethicone, Glycerin, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Undaria Pinnatifida Extract, Triethoxysilylethyl
Polydimethylsiloxyethyl Hexyl Dimethicone, Astrocaryum Tucuma Seed Butter, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum
Seed Butter, Tetrahexyldecyl Ascorbate, Dunaliella Salina Extract, Bisabolol, Ubiquinone, Ergothioneine,Tremella Fuciformis Sporocarp Extract,
Tocopheryl Acetate, Betaine, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyglyceryl-3 Diisostearate, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,
C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, 77499, 77492)

Other Information

Protect this product from excessive heat and direct sun.

Product Label

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Image Description (Image 002)

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