Active Ingredients
Zinc Oxide (Z-Cote® HPI) 7.5%
Titanium Dioxide 5.0%
Solbar Sunscreen 40 Shield Cream
FDA Label NDC 0096-0692
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 Shield (NDC 0096-0692). 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, use, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 a contact Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure and massage in gently, allowing it to dry.
- 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 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-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor.
Other Information
Store away from excessive heat or cold.
Inactive Ingredients
Water (Aqua), Glyceryl Stearate, Oleth-3 Phosphate, PVP/Hexadecene Copolymer, Dimethicone, Isobutyl Stearate, C12-15 Alkyl Benzoate, Cetearyl Ethylhexanoate (and) Isopropyl Myristate, Glycerin, Benzyl Alcohol, Glyceryl Stearate (and) PEG-100 Stearate, Tocopheryl Acetate, Xanthan Gum, Aminomethyl Propanol, Disodium EDTA, Aloe Barbadensis Leaf Extract, Citric Acid
Otc - Questions
Questions? Please call 1 (800) 423-2341
Person & Covey, Inc. Glendale, California 91201, U.S.A.
MADE IN USA
personandcovey.com
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