Avobenzone, Homosalate, Octisalate

Product NDC
11344-943
11-digit product format
113440943
Labeler code
11344
Product ID
11344-943_4ceb123b-d7bf-f068-e063-6394a90af7a1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-08
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 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
HOMOSALATE120 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
af052521-bfa6-4142-a10b-ef51f474a077Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-943-34Avobenzone, Homosalate, Octisalate156 g in 1 BOTTLE, SPRAYSPRAY1563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-943AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [CONSUMER PRODUCT PARTNERS, LLC]1Current NDC, 1 package rows20241109_af052521-bfa6-4142-a10b-ef51f474a077.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 28 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ILIA SUPER SERUM SKIN TINT (ST10 PORTO FERRO)ZINC OXIDEIlia, Inc.b595a378-3285-bea2-e053-2995a90aedbf2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST15 PORTO COVO)ZINC OXIDEIlia, Inc.b595db16-796c-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2 TULUM)ZINC OXIDEIlia, Inc.b5939cc9-4eab-5f73-e053-2995a90a7a7b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST8 SHELA)ZINC OXIDEIlia, Inc.b5956413-af6b-11bd-e053-2a95a90a90472026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST9 PALOMA)ZINC OXIDEIlia, Inc.b5959358-0d93-aa37-e053-2995a90acdae2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST1 RENDEZVOUS)ZINC OXIDEIlia, Inc.b592225c-904e-350a-e053-2a95a90adc2b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST7 DIAZ)ZINC OXIDEIlia, Inc.b5954732-66d7-53db-e053-2995a90a2a3b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST4 FORMOSA)ZINC OXIDEIlia, Inc.b594d426-a79e-19e9-e053-2995a90aa6652026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST3 BALOS)ZINC OXIDEIlia, Inc.b594bc81-d164-bda7-e053-2995a90a69ad2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST18 MALI)ZINC OXIDEIlia, Inc.b59608e6-a407-75dc-e053-2995a90a25cf2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST19 LOVINA)ZINC OXIDEIlia, Inc.b9805c9c-0513-2386-e053-2995a90a21852026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST5 BOM BOM)ZINC OXIDEIlia, Inc.b594f910-f1bc-2bcf-e053-2995a90aebee2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17.5 PERISSA)ZINC OXIDEIlia, Inc.b9805059-583d-e3da-e053-2a95a90a4f652026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14.5 HONOPU)ZINC OXIDEIlia, Inc.b9803596-c090-463f-e053-2a95a90a02342026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6.5 KAI)ZINC OXIDEIlia, Inc.b97f5589-069d-7e93-e053-2a95a90a19a92026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12.75 PAPAKOLEA)ZINC OXIDEIlia, Inc.b97fa903-4a0f-064e-e053-2a95a90a1c612026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16.5 JARDIN)ZINC OXIDEIlia, Inc.b980155b-98f1-6460-e053-2a95a90a58a22026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13.5 RIALTO)ZINC OXIDEIlia, Inc.b97fadb3-fa6e-26b0-e053-2a95a90abfd52026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST9.5 BAIKAL)ZINC OXIDEIlia, Inc.b97f7fe9-c06e-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12.5 RAMLA BAY)ZINC OXIDEIlia, Inc.b97f9d4d-6bdb-6823-e053-2995a90a51432026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-943-3411344094334156 g in 1 BOTTLE, SPRAY (11344-943-34) 156 g2024-11-08NoNoCurrent