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 firm2026-10-12
excluded packagepackage82975-10182975-101-01DDiscontinued by firm2026-10-12

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 26 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRMTLGY Lip Silk - BoldZINC OXIDEDRMTLGY52be6cdf-9ee5-6ce5-e063-6294a90a60752026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - SoftZINC OXIDEDRMTLGY52be975c-6a2a-cf21-e063-6294a90a7c1d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - GlowZINC OXIDEColorescience52bf01e8-0b4a-5985-e063-6294a90a62c02026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - SavannaZINC OXIDEColorescience52bebdba-6387-cc66-e063-6394a90aa35d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Violet HazeZINC OXIDEColorescience52befadc-636f-22bc-e063-6394a90acd182026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Pink SkyZINC OXIDEColorescience52bf204a-ce4e-6e01-e063-6394a90aa9762026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Golden HourZINC OXIDEColorescience52bf2d73-81ad-d455-e063-6294a90a917c2026-05-26WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Cherry NoirZINC OXIDEBlack Girl Sunscreen5290839a-c84b-b0ec-e063-6394a90abec72026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop French KissZINC OXIDEBlack Girl Sunscreen52909e40-1450-250f-e063-6294a90a8a902026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Red WineZINC OXIDEBlack Girl Sunscreen52910220-75f6-23d5-e063-6394a90a9ff32026-05-24WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PopsicleZINC OXIDERiversol529ba685-b4db-37fb-e063-6294a90a54be2026-05-24WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield ImpactZINC OXIDEMental Skin52856524-69d3-90ae-e063-6394a90abc852026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield InspireZINC OXIDEMental Skin52854049-ddc2-2d61-e063-6294a90aa22b2026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield IntentZINC OXIDEMental Skin52856573-d3c0-55b9-e063-6294a90a1b092026-05-23WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGuangzhou Danting Bath&Body Care Industry Co. Ltd5268de18-65dc-4253-e063-6394a90a6d4f2026-05-22WarningsExact identifier
application number: M020
Freaks of Nature Daily Defender Broad Spectrum SPF 30FREAKS OF NATURE DAILY DEFENDER BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.5252e628-9db9-110d-e063-6394a90a8e1d2026-05-21WarningsExact identifier
application number: M020
Hampton Sun SPF 30AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLCeae99a09-9d9e-459d-af96-aef95a854f942026-05-21Exact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Bronze)ZINC OXIDEColorescience9f303e48-037b-6a48-e053-2a95a90a7cf12026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Berry)ZINC OXIDEColorescience9f2edb30-b3d6-23dc-e053-2995a90a03dc2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Blush)ZINC OXIDEColorescience9f2f7133-1c93-8441-e053-2995a90ab09a2026-05-21WarningsExact 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