Avobenzone, Homosalate, Octisalate

Product NDC
55910-936
11-digit product format
559100936
Labeler code
55910
Product ID
55910-936_4c10efba-c436-edc0-e063-6294a90aea4f
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-29
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 150; 50 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ef48288b-533f-4924-ba12-fc8cb83643d42026-03-02WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Flammable: Keep away from fire or flame. after application, wait until product dries before approaching a source of heat or flame, or before smoking

Additional Listing Data#

Finished product
Yes
Brand name base
Avobenzone, Homosalate, Octisalate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE150 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-936-14Avobenzone, Homosalate, Octisalate156 g in 1 CANSPRAY1564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-936AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [OLD EAST MAIN CO.]3Current NDC, 1 package rows20250515_ef48288b-533f-4924-ba12-fc8cb83643d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-936-1455910093614156 g in 1 CAN (55910-936-14) 156 g2023-06-29NoNoCurrent