Solbar Sunscreen 35 Avo Cream
FDA Label NDC 0096-0690

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 35 Avo (NDC 0096-0690). 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, uses, 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Company Information

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Active Ingredient

Homosalate 8.0%

Octinoxate 7.5%

Oxybenzone 6.0%

Avobenzone 3.0%

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

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 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 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 of age: Ask a doctor.

Other Information

Store away from excessive heat or cold.

Inactive Ingredients

Water (Aqua), Isobutyl Stearate, Glycerin, Benzyl Alcohol, Simethicone, Cetyl Phosphate, Triethanolamine, Stearic Acid, Silica, Carbomer 1342, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA

Questions?

Please call 1 (800) 423-2341