Topcare Everyday Ultimate Sheer Sun Broad Spectrum Spf 55 Lotion
FDA Label NDC 36800-167

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Everyday Ultimate Sheer Sun Broad Spectrum Spf 55 (NDC 36800-167). 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 ingredients, purpose, uses, warnings, do not use ​​, when using this product​, stop use and ask a doctor, ​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

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 7.0%,

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

Do Not Use ​​

  • ​on damaged or broken skin

When Using This Product​

  • ​keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

​ if 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 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 time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

water, butyloctyl salicylate, tridecyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, behenyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, dimethicone, tocopheryl acetate, ethylhexylglycerin, caprylyl methicone, ethylhexyl stearate, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, fragrance

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

* Please review the disclaimer below.