Active Ingredients
Meradimate 5.0%
Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 5.0%
Pro-tect Sunscreen For Professionals
FDA Label NDC 61619-866
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-cute Derm, Incorporated for the product Pro-tect Sunscreen For Professionals (NDC 61619-866). 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, uses, warnings, keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
• Pro-Tect® SPF 30+ Broad-Spectrum UVA & UVB protection. • Helps prevent sunburn. • Retains a SPF of 30+ after 80 minutes of activity in water or perspiring. • Provides high protection against sunburn and tanning. • For skin highly sensitive to sunburn.
Warnings
• External use only. • When using this product, keep out of eyes. • Rinse with water to remove. • Stop use and ask a doctor if rash or irritation develops and lasts. • Do not use if sensitive to any of the ingredients or their related compounds.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Directions
•Apply this product topically to affected areas and allow to dry without rubbing. •Use up to 3 times daily. •Use only as directed.
Inactive Ingredients
Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.
Other Information
• Daily usage of Pro-Tect® SPF 30+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. • This product provides more than 30 times your natural protection against sunburn. • Very Water Resistant UVA & UVB Broad-Spectrum Protection. • This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.
Questions Or Comments
Bio-Medical & Pharm. Mfg. Corp., 4311 South Dr.,Houston, TX 77053-4820, 281-835-8051, M-F 8AM-5PM, www.protectsunscreen.com
Package Label
Questions or Comments
A-Cute Derm, Inc.
1810 Cravens Road
Stafford, TX 77477
800.922.2883
M-F 8:30am-5:30pm
www.a-cutederm.com
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