The following Structured Product Label (SPL) was submitted to the FDA by Person And Covey for the product Solbar Shield Spf40 (NDC 0096-0682). 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 indications and use, purpose, keep out of the reach of children, dosage and administration, warnings, otc - active ingredient section, inactive ingredient section, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Dosage and Administration: Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.
Sunscreen
Yes. If swallowed, get medical help or contact a Poison Control Center right away.
Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.
For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.
Homosalate
Octinoxate
Oxybenzone
Avobenzone
Water
Isobutyl Stearate
Glycerin
Benzyl Alcohol
Simethicone
Cetyl Phosphate
Triethanolamine
Stearic Acid
Silica
Carbomer 1342
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Disodium EDTA
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