Otc - Active Ingredient
Active ingredients
avobenzone (3%)
homosalate (10%)
octisalate (5%)
octocrylene (10%)
Sunscreen Spf30 Lotion
FDA Label NDC 71513-708
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Broder Bros Prime Line for the product Sunscreen Spf30 (NDC 71513-708). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Use • Helps prevent sunburn
Warnings
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Apply liberally for 15 minutes before sun exposure and as needed.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months of age: Ask a doctor.
Inactive Ingredient
Inactive ingredients
Acrylate/Beheneth-25 Methacrylate Copolymer, Bisabolol, Caprylyl Glycol, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Phenoxyethanol, Potassium Cetyl Phosphate, Triethanolamine, VP/Hexadecene Copolymer, Water
Other Information
Protect the product in this container from excessive heat and direct sun.
Otc - Questions
Questions?1-800-873-7746 M-F 8am-5pm EST
Package Label.Principal Display Panel
Sunscreen
SPF30
Net 1 FL OZ (29.6ML)
Dist. by Broder Bros., Co. dba alphabroder Gaffney, SC 29341
Made in China
* Please review the disclaimer below.
