Topcare Daily Facial
FDA Label NDC 36800-326

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 Daily Facial (NDC 36800-326). 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, do not use on, 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 Ingredient

Avobenzone 3.0%

Octocrylene 10.0%

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: 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

Other Information

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

Inactive Ingredients

water, disopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 alkylacrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

Package/Label Principal Display Panel - Carton Label

TopCare®

Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen

non-greasy and lightweight

protects from UVA and UVB rays

non-comedogenic (won't clog pores)

fragrance-free and paba-free

dermatologist tested

*Compare to Cetaphil® Daily Facial Moisturizer SPF 15 Ingredients

4 FL OZ (118 mL)

DISTRIBUTED BY TOPCO
ASSOCIATES LLC
7711 GROSS POINT ROAD,
SKOKIE, IL 60077 © TOPC ELL512
QUESTIONS? 1-888-423-0139
[email protected]

Carton Label (74892da6 Bc3b 4f3b Bcb4 A54bcb1a3ddd 01)

Carton Label (74892da6 Bc3b 4f3b Bcb4 A54bcb1a3ddd 01)

Carton Label

* Please review the disclaimer below.