FDA.reportPublic FDA data

Avebonzone, Homosalate, Octisalate

Product NDC
76162-979
11-digit product format
761620979
Labeler code
76162
Product ID
76162-979_5865f0e5-14b3-c4bf-e063-6294a90a4710
Type
HUMAN OTC DRUG
Nonproprietary name
Avebonzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-06
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
Avebonzone, 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
5865f0e5-14b2-c4bf-e063-6294a90a4710Available on FDA.report

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 195 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum 50 Premium Moisturizing Sunscreen Roll-OnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c58c9c7-ca9e-d012-e063-6394a90a5aa92025-08-14WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a003d82-90bd-f541-e063-6394a90ac9062025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a00e4fb-6bf2-4c44-e063-6294a90a61bf2025-08-14WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a0f99df-e6c0-71d9-e063-6294a90a4c9e2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral SunscreenZINC OXIDESun Bum, LLC3a13d4f1-c158-7fa0-e063-6294a90a6fb42025-08-14WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a147fe1-0dda-5433-e063-6394a90a1a592025-08-14WarningsExact identifier
application number: M020
Sun Bum 15 Premium Sunscreen BrowningAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c5b0db8-f05a-2b5c-e063-6294a90ae79b2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aaf7d28-b306-b416-e063-6294a90a021e2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a263b85-e7a0-c068-e063-6294a90a49f22025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen Roll-OnTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a392237-019d-2384-e063-6394a90a5b242025-08-14WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - BonfireHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3a3b3b4a-148c-1dc5-e063-6394a90a7bdb2025-08-14WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude BeachHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac48eef-f651-af96-e063-6294a90a501e2025-08-14WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV6a398dad-2fb9-4cdb-86c5-2a392b88f29b2025-08-13WarningsExact identifier
application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40ZINC OXIDEALL THE RAJE, LLC9ffbd53b-1295-42b4-9cd5-18cbb75921d02025-08-13WarningsExact identifier
application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, BistreZINC OXIDEPower Beauty Co.2e6eac42-0b70-44ea-e063-6294a90a49f82025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c414e9b-6c3e-2c8d-e063-6394a90af4a62025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c443347-0134-8c87-e063-6294a90a80462025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3a22f0b9-2d6d-6230-e063-6294a90adf312025-08-13WarningsExact identifier
application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3c4567d6-879e-f995-e063-6394a90a319f2025-08-13WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-979-1476162097914156 g in 1 CAN (76162-979-14) 156 g2026-08-06NoNoCurrent