Sun Bum Signature Spf 30 Sunscreen Lip Balm
FDA Label NDC 69039-277

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 Signature Spf 30 Sunscreen Lip Balm (NDC 69039-277). 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

Zinc oxide 8%

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

  • 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 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 this product from excessive heat and direct sun.

Inactive Ingredients

prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, cera alba (beeswax), euphorbia cerifera (candelilla) wax, argania spinosa kernel (argan) oil, caprylic/capric triglyceride, tocopheryl acetate, copernicia cerifera (carnauba) wax, tocopherol, glycine soja (soybean) oil, glyceryl caprylate, bisabolol, polyhydroxystearic acid, polyglyceryl-3-polyricinoleate, isostearic acid, lecithin, glyceryl undecylenate

Questions Or Comments?

Call +1 (877) 978-6286

Package Labeling:

Label2 (Label2)

Label2 (Label2)

* Please review the disclaimer below.