Active Ingredients
Zinc Oxide 25%
Sensible Spf 32 Mineral Sunscreen
FDA Label NDC 82751-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kindred Bravely for the product Sensible Spf 32 Mineral Sunscreen (NDC 82751-101). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Purpose
Sunscreen
Indications & Usage
Uses:
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.
Warnings
For External Use Only
Otc - Do Not Use
Do not use on damaged or 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 appears
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If
product is swallowed, get medical help
or contact Poison Control Center right
away.
Dosage & Administration
Directions
- Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure
- Children under 6 months of age: ask a doctor
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- 40 minutes of swimming or sweating
- Immediately after towel drying
- at least every 2 hours
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:
Reapply after:
Other Safety Information
Other Information: Protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments? 888-850-3756 or Kindredbravely.com
* Please review the disclaimer below.
