FDA.reportPublic FDA data

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 firm2026-10-16
excluded packagepackage82975-10182975-101-01DDiscontinued by firm2026-10-16

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 86 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
application number: M020
FACE SPF 47 SETTINGFACE SPF 47 SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47db9a54-c02f-d2ea-e063-6394a90ab9732026-01-08WarningsExact identifier
application number: M020
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
application number: M020
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact 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