Sun Bum Spf 70 Premium Moisturizing Sunscreen Spray
FDA Label NDC 69039-227

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum, Llc for the product Sun Bum Spf 70 Premium Moisturizing Sunscreen (NDC 69039-227). 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.

Active Ingredients

Avobenzone 3.00%, Homosalate 10.00%,

Octisalate 5.00%, Octocrylene 10.00%

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

Flammable: Contents under pressure. Do not puncture or inciinerate. Do not store at temperatures above 120°F. Do  not use in the presence of a flame or spark keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do Not Use

on damaged or broken skin.

When Using This Product:

Keep away from face to avoid breathing it. 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

  • Hold container 4 to 6 inches from the skin to apply.
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • Do not spray directly into face. Spray on hands then apply to face.
  • Do not apply in windy conditions. Use in well-ventilated area.
  • Reapply: After 80 minutes of swimming or sweating.
  • Immediately after towel drying. 
  • 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 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol Denat.(64%), Polyester-8, Acrylates/Octylacrylamide Copolymer, Dimethicone, PPG-5-Ceteth-20, Acrylates/Dimethicone Copolymer, Cyclopentasiloxane, Fragrance, Tocopheryl Acetate, Trisiloxane, Ascorbyl Palmitate.

Questions Or Comments?

Call +1 (877) 978-6286

Package Labeling:

Label23 (Label23)

Label23 (Label23)

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