Active Ingredients
Homosalate 8.0 %
Octinoxate 7.5%
Zinc Oxide 8.1%
Burnd Lotion
FDA Label NDC 85455-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Burnd Llc for the product Burnd (NDC 85455-100). 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:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early skin aging caused by the sun
Warnings:
•
For external use only.
•
Do not use on damaged or broken skin.
•
When using this product, keep out of eyes. Rinse with water to remove.
•
Stop use and ask a doctor if rash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Apply liberally 15 minutes before sun exposure.
• REAPPLY: • After 80 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 ofskin 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:
- Limit time in the sun, especially from 10 a.m. to 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months of age: Ask a doctor.
Other Information:
- Protect the product in this container from excessive heat and direct sun.
- May stain some fabrics.
Inactive Ingredients:
Aluminum Starch Octenylsuccinate,Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax,Caprylhydroxamic Acid, Caprylyl Glycol, Cyclopentasiloxane,Decyl Glucoside, Diethylhexyl Sebacate, Ethylhexylglycerin,Hydrogenated Castor Oil, Methylpropanediol, PEG/PPG-20/15 Dimethicone, PEG-30 Dipolyhydroxystearate,Polysilicone-11, Propanediol, Silica, Sodium Chloride,Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua)
Package Label.Principal Display Panel
From the Dr. that pretty much invented sunscreen
burnd
Broad Spectrum SPF 41
Water Resistant
80 minutes
3.4 fl. oz./100 mL
Distributed by burnd,Inc,
East Hampton, NY 11937
800-621-5816
burnd is a registered trademark of burnd, inc.
Label
* Please review the disclaimer below.
