FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate

Product NDC
75712-935
11-digit product format
757120935
Labeler code
75712
Product ID
75712-935_4c10ea4b-f643-07f7-e063-6294a90a41a3
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 150; 50 mg/mL; mg/mL; mg/mL
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.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier

Warnings cross-check#

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

warnings

Warnings For external use only

Adverse reactions cross-check#

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

adverse reactions

Adverse Reactions 100% Satisfaction Guaranteed! (888) 309-9030 DISTRIBUTED BY OLD EAST MIN CO. 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

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/mL
HOMOSALATE150 mg/mL
OCTISALATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-935-21Avobenzone, Homosalate, Octisalate88 mL in 1 TUBELOTION884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-935AVOBENZONE, HOMOSALATE, OCTISALATE LOTION [DOLLAR GENERAL CORPORATION]2Current NDC, 1 package rows20241013_8f4a6a31-2fae-42fe-924f-10237c59e791.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-935-217571209352188 mL in 1 TUBE (75712-935-21) 88 ml2023-08-01NoNoCurrent