Solbar Sunscreen 40 Zinc Cream
FDA Label NDC 0096-0691

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 Sunscreen 40 Zinc (NDC 0096-0691). 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 ingredient, purpose, use, warnings, keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredient

→ Otc - Questions

→ Company Information

→ Package Label.principal Display Panel

Active Ingredient

Homosalate 10.0%

Ethylhexyl

Methoxycinnamate 7.5%

Zinc Oxide 7.5%

Purpose

Sunscreen

Use

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

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 and evenly 15 minutes before sun exposure.
Reapply to dry skin:
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 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.
Children under 6 months: Ask a doctor.

Other Information

Store away from excessive heat or cold.

Inactive Ingredient

Water (Aqua), Butyl Stearate, Glyceryl Stearate (and) PEG-100 Stearate, Glycerin, Dimethicone, Glyceryl Dilaurate, PVP (and) VP/Eicosene Copolymer, Cetyl Alcohol, Cetyl Phosphate, Cyclomethicone, Ceteareth-20 (and) Cetearyl Alcohol, Benzyl Alcohol, Xanthan Gum, Aminomethyl Propanol, Disodium EDTA, Citric Acid

Otc - Questions

Questions? Please call 1 (800) 423-2341