FDA.reportPublic FDA data

AVOBENZONE, HOMOSALATE, OCTISALATE

Product NDC
76162-942
11-digit product format
761620942
Labeler code
76162
Product ID
76162-942_5864275d-a481-06f8-e063-6394a90aecab
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, 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; 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
5864275d-a480-06f8-e063-6394a90aecabAvailable 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 109 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bella Blue Skin Care Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f663fe5-fdfe-d793-e063-6394a90a4f0b2025-12-17WarningsExact identifier
application number: M020
Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3aadc018-edbb-033b-e063-6394a90afbe72025-12-17WarningsExact identifier
application number: M020
Non-Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3ab0298d-b2d0-591e-e063-6394a90a31772025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3ccea6c0-8c27-6b26-e063-6294a90a09312025-12-17WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEJKH Aesthetics LLC369c1d16-5980-e1dc-e063-6394a90a31042025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3d5ab3f6-10b9-2a21-e063-6294a90a34282025-12-17WarningsExact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364cafdd-fe86-cb23-e063-6394a90afb092025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364d2231-3db3-0a59-e063-6394a90a67772025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-942-1476162094214156 g in 1 CAN (76162-942-14) 156 g2026-08-06NoNoCurrent