Hydrating Body Sunscreen

Product NDC
82975-101
11-digit product format
829750101
Labeler code
82975
Product ID
82975-101_e8bb47dd-7d81-1647-e053-2995a90ac881
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
frank body
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-12-31
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82975-101DDiscontinued by firm2026-10-30
excluded packagepackage82975-10182975-101-01DDiscontinued by firm2026-10-30

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82975-101-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82975-101-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage82975-101-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82975-101-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82975-101-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82975-101-012025-02-01C16284748780-12cef2736-ace4-d83d-e063-dadaa90ab31fHydrating Body Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82975-101HYDRATING BODY SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [FRANK BODY]2Legacy NDC20250201_e8bb47dd-7d80-1647-e053-2995a90ac881.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 264 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
application number: M020
Prevention Daily Matte Moisturizer SPF 30ZINC OXIDE AND HOMOSALATEAllure Labsf0fb1b69-53f2-efff-e053-2995a90af9d42024-12-09WarningsExact identifier
application number: M020
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF 30 TintedZINC OXIDEAllure Labsf1761b09-9061-a052-e053-2a95a90a39c82024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF30ZINC OXIDEAllure Labsf188669f-7b9f-6e01-e053-2995a90afa3c2024-12-09WarningsExact identifier
application number: M020
Prevention Clear Solar Gel SPF30AVOBENZON, OCTISALATE AND OCTOCRYLENEAllure LAbsf19f6d9b-5249-27a6-e053-2a95a90a8a392024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen TintedZINC OXIDEAllure Labs02e7fb00-2039-c4f8-e063-6294a90a418f2024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen UntintedZINC OXIDEAllure Labs02f9c859-8d7d-5146-e063-6394a90a57b52024-12-09WarningsExact identifier
application number: M020
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
application number: M020
Tinted Face Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC0d7300ee-adf4-41be-bb9f-257cd2986c0f2024-12-06WarningsExact identifier
application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST289b824f-bb0b-313e-e063-6394a90ab7832024-12-06WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d840001-a648-df1b-e063-6294a90ab2992024-12-06WarningsExact identifier
application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30ZINC OXIDE, OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC1629f061-b8fc-4fda-8378-c64e164d41bd2024-12-06WarningsExact identifier
application number: M020
Clear System Brightening Day Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC8cbc8fa4-469f-4fa3-bd8e-27e815989c3f2024-12-06WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 27ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.c4e16cec-c7db-4e5e-9d05-5d7afdb790912024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No29OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3fc90114-4cdf-273e-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 31ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95862d15-d977-7276-e053-2995a90ab6902024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB Cream SPF42 No. 25ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9c6f48b1-007b-434f-b756-242e3390e9b72024-12-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82975-101-0182975010101140 mL in 1 BOTTLE, PLASTIC (82975-101-01) 140 ml2022-12-310000-00-00NoNoCurrent