FDA.reportPublic FDA data

Sunscreen

Product NDC
55910-012
11-digit product format
559100012
Labeler code
55910
Product ID
55910-012_4c10c12b-2e1f-8b32-e063-6294a90a18e9
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate,Otisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE150 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-012-14Sunscreen156 g in 1 CANSPRAY15620
55910-012-15Sunscreen258 g in 1 CANSPRAY25820
55910-012-39Sunscreen312 g in 1 CANSPRAY31220

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-012SUNSCREEN (AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE) SPRAY [OLD EAST MAIN CO]18Current NDC, Legacy NDC, 3 package rows20241013_2ea288fe-815d-4568-9592-55ea428448fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-012-1455910001214156 g in 1 CAN (55910-012-14) 156 g2019-10-010000-00-00NoNoCurrent
55910-012-1555910001215258 g in 1 CAN (55910-012-15) 258 g2019-10-010000-00-00NoNoCurrent
55910-012-3955910001239312 g in 1 CAN (55910-012-39) 312 g2019-10-010000-00-00NoNoCurrent