Drug Facts
Pro-Tect® SPF 15+ Sunscreen Broad-Spectrum UVA/UVB Protection & Moisturizing Lotion
Pro-tect Everyday Sunscreen Spf 15
FDA Label NDC 61619-868
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 Everyday Sunscreen Spf 15 (NDC 61619-868). 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 drug facts, active ingredients, purpose, uses, warnings, 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
Active Ingredients
Octinoxate...........................................................7.5%
Oxybenzone.........................................................2.0%
Padimate O...........................................................5.0%
Purpose
Sunscreen
Uses
•Pro-Tect® SPF 15+ Broad-Spectrum UVA & UVB protection. •Helps prevent sunburn. •Retains a SPF
of 15+ after 80 minutes of activity in water of 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 of their related compounds.
Directions
•Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed.
•Children under 6 months of age: ask a doctor.
Inactive Ingredients
Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked),
Cetyl Alcohol, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate,
Iodopropynyl Butylcarbamate, Trolamine, Water.
Other Information
•Daily usage of Pro-Tect SPF15+ may help reduce the chance of premature aging of the skin due to
overexposure to the sun. •This product provides more than 15 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.bio-medicalmanufacturing.com
Principal Display Panel
1 Oz Sunscreen (86005 1oz V 101315 V2)
SPF 15
Sunscreen
29.6 grams
NDC:61619-868-07
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