Sun Bum Clear Zinc Spf 50 Sunscreen
FDA Label NDC 69039-608

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 Clear Zinc Spf 50 Sunscreen (NDC 69039-608). 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

Homosalate 10%, Octisalate 5%,
Octocrylene 10%, Zinc oxide 7%

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 immediately.

Directions

• shake well before use
• 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 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

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl palmitate, ethylhexyl stearate, cetyl PEG/PPG-10/1 dimethicone, glycerin, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiable, isoamyl cocoate, hydrogenated castor oil, hydrated silica, polyethylene, tocopheryl acetate, theobroma cacao (cocoa) seed butter, aloe barbadensis leaf juice, beeswax, fragrance, sodium chloride, triethoxycaprylylsilane, phenoxyethanol, ethylhexylglycerin

Other Information

• protect this product from excessive heat and direct sun
• keep outer card for complete directions and warnings

Questions?

call 1 (877) 978-6286

* Please review the disclaimer below.