Max Sheer All Day Moisture Defense
FDA Label NDC 54031-324

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peter Thomas Roth Labs Llc for the product Max Sheer All Day Moisture Defense (NDC 54031-324). 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 drug facts, purpose, warnings, otc - do not use, when using this product, otc - stop use, otc - keep out of reach of children, ​directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%
Homosalate 10%
Octinoxate 7.5%
Octisalate 5%
Octocrylene 2%
Oxybenzone 6%

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 - Do Not Use

  • Do not use on damaged or broken skin

When Using This Product

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • 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
  • use a water resistant sunscreen if involved in swimming or intense physical activities where sweating will occur
  • reapply at least every 2 hours
  • 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 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses 
  • children under 6 months: Ask a doctor

​Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, Bentonite, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Ceramide 3, Cetyl Alcohol, Dimethicone, Ginkgo Biloba Leaf Extract, Glyceryl Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Phospholipids, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Sodium Benzoate, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water/Aqua/Eau.

​Other Information

protect this product from excessive heat and direct sun

​Questions Or Comments?

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