Sun Bum Mineral Sunscreen Broad Spectrum Spf 50
FDA Label NDC 69039-624

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 Mineral Sunscreen Broad Spectrum Spf 50 (NDC 69039-624). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Titanium dioxide 3.4%

Zinc oxide 16%

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.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Do not store at room temperature above 120°F.

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
  • hold container 4 to6 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.
  • children under 6 months of age: ask a doctor.
  • Sun Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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

Other Information

protect this product from excessive heat and direct sun.

Inactive Ingredients

water, butyloctyl salicylat, helianthus annus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum,bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroxamic acid

Questions?

1-877-978-6286

Package Labeling:

Label5 (Label5)

Label5 (Label5)

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