FDA.reportPublic FDA data

burnd - BURND LLC

Manufacturer
BURND LLC
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:51:38

Label at a glance#

Productburnd
Active ingredientHOMOSALATE, OCTINOXATE, ZINC OXIDE
Label structure9 sections

Indications and 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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 8.0 %

Octinoxate 7.5%

Zinc Oxide 8.1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

• For external use only.
• Do not useon damaged or broken skin.
• When using this product, keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctorif rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

BURNBURN

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850056302111GTIN-13: 0850056302111
EAN-13: 0850056302111
GTIN-12: 850056302111
UPC-A: 850056302111
GTIN storage (14 digits): 00850056302111		BURND.jpg
QR code linkQR Codewww.physikusa.com/BURND.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85455-100-01burnd100 mL in 1 TUBELOTION1007
85455-100-61burnd7.5 mL in 1 PACKETLOTION7.57
85455-100-62burnd5.9 mL in 1 PACKETLOTION5.97

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85455-10085455-100-01, 85455-100-61, 85455-100-62

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
WATER059QF0KO0RIACT
DIETHYLHEXYL SEBACATEU9LS47Q72QIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
BIS-PEG-12 DIMETHICONE (70 MPA.S)2JDK5W22H4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG/PPG-20/15 DIMETHICONE06R6X77P9CIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ASCORBYL PALMITATEQN83US2B0NIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-01-28monthly-update2026-06-03 17:53:24

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
burndHOMOSALATE, OCTINOXATE, ZINC OXIDEBURND LLC31cf923e-fdde-790b-e063-6294a90a60ee2026-03-26WarningsExact identifier
ndc (package): 85455-100-01
ndc (package): 85455-100-61
ndc (package): 85455-100-62
ndc (product): 85455-100
ndc11 (package): 85455010062
ndc11 (package): 85455010001
ndc11 (package): 85455010061
spl id: 4df29d85-4168-2ee1-e063-6294a90ab080
spl set id: 31cf923e-fdde-790b-e063-6294a90a60ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.