burnd

Product NDC
85455-100
11-digit product format
854550100
Labeler code
85455
Product ID
85455-100_4df29d85-4168-2ee1-e063-6294a90ab080
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octinoxate, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
BURND LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-09
Substance
HOMOSALATE; OCTINOXATE; ZINC OXIDE
Active strength
8; 7.5; 8.1 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
burnd
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE8 g/100mL
OCTINOXATE7.5 g/100mL
ZINC OXIDE8.1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV06SV4M95S, 4Y5P7MUD51, SOI2LOH54Z

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85455-100BURND (HOMOSALATE, OCTINOXATE, ZINC OXIDE) LOTION [2 OARS INVESTMENTS DBA BURND]1Current NDC, 3 package rows20250410_31cf923e-fdde-790b-e063-6294a90a60ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85455-100-0185455010001100 mL in 1 TUBE (85455-100-01) 100 ml2025-04-09NoNoCurrent
85455-100-61854550100617.5 mL in 1 PACKET (85455-100-61) 7.5 ml2025-04-09NoNoCurrent
85455-100-62854550100625.9 mL in 1 PACKET (85455-100-62) 5.9 ml2025-04-09NoNoCurrent