Other
Drug Facts
Cb 101
FDA Label NDC 71160-191
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tekweld Solutions, Inc. for the product Cb 101 (NDC 71160-191). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, other safety information, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients:
Octinoxate 7.5%
Oxybenzone 3.5%
Otc - Purpose
Purpose:
Octinoxate ..............................Sunscreen
Oxybenzone ...........................Sunscreen
Indications & Usage
Uses:
- 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.
Other Safety Information
For external use only.
Other information
• Protect this product from excessive heat and direct sun
Otc - Do Not Use
Do not use on broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask doctor: if rash or irritation develops and persists.
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 15 minutes before sun exposure as needed
• Children under 6 months of age: ask a doctor before use.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
Inactive Ingredient
Inactive Ingredients
Petrolatum, Ozokerite, Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin,
Copernicia Cerifera (Carnauba) Wax, Tocopherol,
Propylparaben, Methylparaben, Aloe Barbadensis Leaf Extract.
Otc - Questions
Questions or comments? www.tekweld.com MADE IN USA
Product Package
SPF15 Natural • Aloe Vera • Safety Sealed
Peel Back for Drug Facts
Net Wt. 0.15 oz (4.25g)
Distributed by: Tekweld 45 Rabro Dr. Hauppauge, NY 11788
res
* Please review the disclaimer below.
