Sunscreen Spf 70
FDA Label NDC 36800-716

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Top Care for the product Sunscreen Spf 70 (NDC 36800-716). 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%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreen

Uses

Uses • helps prevent sunburn

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 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

Behenyl Alcohol, Benzyl Alcohol, Butylated PVP, Butylene Glycol, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glyceryl Stearate, Lauryl Alcohol, Lecithin, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Water.

Other Information

  • protect this product from excessive heat and direct sun
  • may stain fabrics.

* Please review the disclaimer below.