FDA.reportPublic FDA data

BenzoAzeline 10

Product NDC
78863-1310
11-digit product format
788631310
Labeler code
78863
Product ID
78863-1310_256eec2c-7298-46d3-93bc-e7c41375fd8a
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Noon Aesthetics M.R. Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
BENZOYL PEROXIDE
Active strength
1000 mg/mL
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
BenzoAzeline 10
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE1000 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
985efa19-bd91-45cd-a2a0-d71ec325e51cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-1310-1BenzoAzeline 1050 mL in 1 TUBECREAM502
78863-1310-1BenzoAzeline 101 in 1 CARTONCREAM12
78863-1310-2BenzoAzeline 1015 mL in 1 BOTTLE, PUMPCREAM152
78863-1310-2BenzoAzeline 101 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-1310BENZOAZELINE 10 (BENZOYL PEROXIDE) CREAM [NOON AESTHETICS M.R. LTD]1Current NDC, 4 package rows20240301_985efa19-bd91-45cd-a2a0-d71ec325e51c.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 22 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Play Everyday Sunscreen SPF 50 with Sunflower ExtractAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC0428eebc-4ffb-4981-b738-2c9ecf2a6a2e2026-06-04WarningsExact identifier
application number: M020
Unseen Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESupergoop LLC21b3491f-7b02-9bc5-e063-6294a90a0dc32026-06-04WarningsExact identifier
application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden HourZINC OXIDESupergoop LLC1f1be2a7-af96-d73d-e063-6394a90acc1a2026-06-04WarningsExact identifier
application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC975402e6-8c74-b18e-e053-2995a90a467e2026-06-04WarningsExact identifier
application number: M020
Derma E Sun Drops SPF 30ZINC OXIDEderma e76c29f24-e0d9-4235-b278-96e609bc58db2026-06-04WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
application number: M020
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
application number: M020
BLDG Active Skin Repair Sun Stick Performance SunscreenZINC OXIDEInnovacyn, Inc.a751fc1d-5ee4-4ecc-8ade-2568d91890c42026-06-02WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCAREHOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5347c9a1-2239-b617-e063-6294a90ac6012026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Hydro Booster Moisture SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEOlive International Co., Ltd.4ea2292a-571c-475c-a64c-cbdd1f51f2422026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Daily Invisible Blurring SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOlive International Inc.42325963-0917-43c4-8fe0-130336c7fa812026-06-02WarningsExact identifier
application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
application number: M020
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
application number: M020
4ocean REEF SAFE SUNSCREEN SPF 40ZINC OXIDEStream2Sea, LLC52d3d97c-a846-4721-acbe-52a525cb20112026-06-01WarningsExact identifier
application number: M020
APRILSKIN MUGWORT CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAPR US INC50a7b64a-8b26-97ac-e063-6294a90ad77a2026-06-01WarningsExact identifier
application number: M020
Ultra Violette Future Screen Broad Spectrum SPF 50ZINC OXIDEGrace and Fire USA Inc.252fdc91-bbe2-58ec-e063-6294a90a50672026-06-01WarningsExact identifier
application number: M020
Ultra Violette Vibrant Screen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.2633a289-b3b2-b614-e063-6294a90ad2142026-06-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78863-1310-1788631310011 TUBE in 1 CARTON (78863-1310-1) / 50 mL in 1 TUBE1 tube2024-03-01NoNoCurrent
78863-1310-2788631310021 BOTTLE, PUMP in 1 CARTON (78863-1310-2) / 15 mL in 1 BOTTLE, PUMP2024-03-01NoNoCurrent