Sun Bum Spf 15 Premium Moisturizing Sunscreen
FDA Label NDC 69039-212

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 15 Premium Moisturizing Sunscreen (NDC 69039-212). 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 2%, Homosalate 5%, Octisalate 2%, Octocrylene 10%

Purpose

Sunscreen

Uses

• Helps prevent sunburn • higher SPF gives more sunburn protection • Ifusedasdirectedwithothersunprotectionmeasures(seeDirections), decreasestheriskofskincancerandearlyskinagingcausedbythesun

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.
• 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 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-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Otherinformation

protectthis product from excessive heat and direct sun

Inactive Ingredients

water, butyloctylsalicylate, hydratedsilica, styrene/acrylatescopolymer, dimethicone, VP/hexadecene copolymer, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone

Questions?

1-877-978-6286

Package Labeling:

Label (Label)

Label (Label)

* Please review the disclaimer below.