FDA.reportPublic FDA data

SUNSCREEN

Product NDC
82953-025
11-digit product format
829530025
Labeler code
82953
Product ID
82953-025_229d8002-259a-f252-e063-6394a90adda1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-30
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
10; 10; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
SUNSCREEN
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
HOMOSALATE10 g/100mL
AVOBENZONE3 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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
229dabbc-9043-3c9d-e063-6394a90a5692Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-025-01SUNSCREEN0110 mL in 1 BOTTLE, PLASTICSPRAY101
82953-025-02SUNSCREEN0120 mL in 1 BOTTLE, PLASTICSPRAY201
82953-025-03SUNSCREEN0125 mL in 1 BOTTLE, PLASTICSPRAY251
82953-025-04SUNSCREEN0115 mL in 1 BOTTLE, PLASTICSPRAY151
82953-025-05SUNSCREEN018 mL in 1 BOTTLE, PLASTICSPRAY81
82953-025-06SUNSCREEN0118 mL in 1 BOTTLE, PLASTICSPRAY181
82953-025-07SUNSCREEN015 mL in 1 BOTTLE, PLASTICSPRAY51
82953-025-08SUNSCREEN0130 mL in 1 BOTTLE, PLASTICSPRAY301
82953-025-09SUNSCREEN0160 mL in 1 BOTTLE, PLASTICSPRAY601
82953-025-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICSPRAY901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-025SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240922_229dabbc-9043-3c9d-e063-6394a90a5692.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 170 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Land Shark SPF 40ZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d204c38c-b5d1-3511-e053-2a95a90a9dc82025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e4e63c-3e51-0a78-e053-2a95a90abd872025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.8cd68b09-2578-4519-b00e-e83e0e4408152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e44be7-3a46-34e2-e053-2a95a90a96602025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.005a9e7c-e392-4b9a-911f-d7586f7ae94e2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559d349-2ffd-492c-e053-2995a90aab062025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pink BeachZINC OXIDETropical Seas, Inc.d240e6c9-d053-9924-e053-2a95a90a855a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e49c6f-477b-aafc-e053-2a95a90a982a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559e03b-f5d3-bd72-e053-2995a90a31ca2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50 SportOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e40a7c-b49d-cfc3-e053-2995a90ac27e2025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e24ca1-d041-355d-e053-2995a90a3d612025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5570cbd-89f5-65d5-e053-2995a90a54d12025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Azure BlueZINC OXIDETropical Seas, Inc.d23fe61a-3ffb-59d0-e053-2995a90a59e62025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b55a0bd0-2a32-2977-e053-2a95a90aa1422025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.06d43525-86d8-f2d9-e063-6394a90afc812025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pacific PurpleZINC OXIDETropical Seas, Inc.d240fe7c-9d16-78c9-e053-2a95a90a763c2025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.06c1ac52-474c-db5c-e063-6294a90afb5f2025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-025-018295300250110 mL in 1 BOTTLE, PLASTIC (82953-025-01) 10 ml2024-05-30NoNoCurrent
82953-025-028295300250220 mL in 1 BOTTLE, PLASTIC (82953-025-02) 20 ml2024-05-30NoNoCurrent
82953-025-038295300250325 mL in 1 BOTTLE, PLASTIC (82953-025-03) 25 ml2024-05-30NoNoCurrent
82953-025-048295300250415 mL in 1 BOTTLE, PLASTIC (82953-025-04) 15 ml2024-05-30NoNoCurrent
82953-025-05829530025058 mL in 1 BOTTLE, PLASTIC (82953-025-05) 8 ml2024-05-30NoNoCurrent
82953-025-068295300250618 mL in 1 BOTTLE, PLASTIC (82953-025-06) 18 ml2024-05-30NoNoCurrent
82953-025-07829530025075 mL in 1 BOTTLE, PLASTIC (82953-025-07) 5 ml2024-05-30NoNoCurrent
82953-025-088295300250830 mL in 1 BOTTLE, PLASTIC (82953-025-08) 30 ml2024-05-30NoNoCurrent
82953-025-098295300250960 mL in 1 BOTTLE, PLASTIC (82953-025-09) 60 ml2024-05-30NoNoCurrent
82953-025-108295300251090 mL in 1 BOTTLE, PLASTIC (82953-025-10) 90 ml2024-05-30NoNoCurrent