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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef48288b-533f-4924-ba12-fc8cb83643d4Available on FDA.report

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

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 45 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arizona Sun SPF 45 Golfblok SunscreenSUNSCREENArizona Sun Products11e74823-5956-4277-e063-6294a90a7e272026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 SunscreenSUNSCREENArizona Sun Products11d54b18-59b2-0d53-e063-6394a90adb022026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products1184c806-756a-3ab5-e063-6394a90adb592026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e336b3-0aee-cc2f-e063-6394a90a9f912026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products11853277-0994-53bd-e063-6394a90a19b12026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products11823514-8c0c-7c85-e063-6294a90a5e692026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products1184f3e0-d11f-92ee-e063-6294a90aaa0b2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products118295c4-644e-19d6-e063-6294a90a35432026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF15SUNSCREENArizona Sun Products10cd4a29-0139-9435-e063-6394a90a51a42026-04-09WarningsExact identifier
application number: M020
Arizona Sun Kids Sunscreen SPF 30SUNSCREENArizona Sun Products10f832e7-c2b5-b847-e063-6294a90a20d52026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products114887d9-10c0-03bc-e063-6294a90ab1662026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF15SUNSCREENArizona Sun Products10d02ba4-6701-865a-e063-6394a90ac9112026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30SUNSCREENArizona Sun Products116e71c4-f443-0b6c-e063-6394a90a0cdd2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Tanning Oil SPF 3TANNING OILArizona Sun Products10b951a4-5a66-4a5e-e063-6394a90af42e2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e4d4b6-23cb-3ee0-e063-6394a90abf9f2026-04-09WarningsExact identifier
application number: M020
Wetsports Arizona Sun Water Resistant SPF 30SUNSCREENArizona Sun Products115cf201-cfef-9b69-e063-6294a90aba642026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF15SUNSCREENArizona Sun Products10cf56d0-ddf9-7cf1-e063-6294a90a99c42026-04-09WarningsExact identifier
application number: M020
Arizona Sun Kids Sunscreen SPF 30SUNSCREENArizona Sun Products10f60367-6681-a589-e063-6394a90a6bb82026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products115b4d4c-51f1-ad62-e063-6294a90a3e532026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e48195-7bae-2422-e063-6394a90a261c2026-04-09WarningsExact identifier
application number: M020

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