Burn Out Spf-30 Sunscreen
FDA Label NDC 55777-0100

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 Research Llc for the product Burn Out Spf-30 Sunscreen (NDC 55777-0100). 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 other, active ingredient, purpose, use(s), warnings, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Zinc Oxide (non-nano) 20%

Purpose

sunscreen

Use(S)

  • Provides high protection against sunburn.
  • Provides broad spectrum (UVA and UVB) protection.
  • Retains SPF after 40 minutes of activity in the water or sweating.
  • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Otc - When Using

When using this product

  • Keep out of eyes. Rinse with water to remove.
  • Stop and ask a doctor if rash or irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: Ask a doctor

Inactive Ingredients

Purified Water, Organic Aloe Barbadensis Leaf Juice

Certified by a USDA third party agency

, Capric/ Caprylic Triglycerides, Sorbitan Stearate, Polyglyceryl-10 Laurate, Cetyl Dimethicone, Magnesium Sulfate, Organic Avocado Oil, Virgin Hemp Seed Oil, Organic Cucumber Extract, Organic Green Tea Extract, Tocopherols, Organic Pomegranate Juice, Helionori, Hyaluronic Acid, Ethylhexylglycerin, Hydrogenated Methyl Abiate, Polyaminopropyl Biguanide.

Other Information

High sun protection product.

Questions?

Call toll free 1-800-798-7970

Principal Display Panel - 100 Ml Tube Label

Burn Out®

BROAD SPECTRUM
SPF 30

OCEAN TESTED
PHYSICAL
SUNSCREEN

No Nanoparticles
Petroleum-free, Paraben-free

Enriched with Antioxidants,
Organic Avocado Oil & Helionori

Water Resistant (40 min)

Principal Display Panel (100 ml Tube Label)

Principal Display Panel (100 ml Tube Label)

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