Florida Glow Face Shield Spf 55 Lotion
FDA Label NDC 83862-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Southeast Holdings Corp. for the product Florida Glow Face Shield Spf 55 (NDC 83862-004). 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, directions, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Homosalate  10%                          
Octocrylene  5%
Zinc Oxide   5.8%

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.

Stop use and ask a doctorif rash or irritation develops and lasts.

Do not useon damaged or broken skin.

When using this productKeep out of eyes.Rinse with water to remove.

Keep out of reach of children. If product is 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: 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 Broad Spectrum of 15 or nigher and other sun protection measures, including:
• limit time in the sun, espec1ally from 10 a.m.- 2 p.m.
• wear long sleeve shirts, pants, hats & sunglasses

Inactive Ingredients

Triethoxycaprylylsilane, Water, Ethylhexyl Stearate, Isopropyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated Polyisobutene , Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Methylisothiazolinone, Caprylyl Glycol, Sodium Chloride, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Silica, Polyglyceryl-3 Oleate

Other Information

• protect this product from heat and direct sun.

Product Label

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