Solbar Fifty Spf50 Cream
FDA Label NDC 0096-0741

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Person And Covey for the product Solbar Fifty Spf50 (NDC 0096-0741). 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 warnings and precautions section, otc - purpose section, indications & usage section, dosage & administration section, otc - keep out of reach of children section, 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.

Warnings And Precautions Section

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.

Otc - Purpose Section

Sun screen

Indications & Usage Section

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 & Administration Section

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.

Otc - Keep Out Of Reach Of Children Section

Yes. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Active Ingredient Section

Octocrylene

Ethylhexyl Methoxycinnamate

Oxybenzone

Avobenzone

Inactive Ingredient Section

Purified Water

Propylene Glycol Diethylhexanoate

Dimethicone

PVP/Eicosene Copolymer

Stearic Acid

Cetyl Phosphate

Glycerin

Benzyl Alcohol

Cetyl Alcohol

Carbomer 1342

Triethanolamine

Package Label.Principal Display Panel

Solbar Fifty.jpg

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