Sun Bum Skin Care Essentials Kit
FDA Label NDC 69039-645

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 Skin Care Essentials Kit (NDC 69039-645). 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 if, 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 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • If used as directed with other sun protection measuress ( 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 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
  • 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 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 (Spf 30 Moisturizing Sunscreen Lotion)

water, polyglyceryl-6 stearate, dimethicone, cetearyl alcohol, capryloyl glycerin/sebacic acid copolymer, hydrated silica, hibiscus sabdariffa fruit extract, niacinamide, cocos nucifera (coconut) fruit extract, helianthus annuus (sunflower) extract, lactobacillus, lactobacillus ferment, musa sapientum (banana) flower extract, musa sapientum (banana) fruit extract, musa sapientum (banana) leaf extract, musa sapientum (banana) peel extract, musa sapientum (banana) pulp extract, lysolecithin, erythritol, glucose, glycerin, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, cetearyl glucoside, fragrance, polyglyceryl-6 behenate, pullulan, sclerotium gum, tocopherol, xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

1-877-978-6286

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