Hydrating Body Sunscreen

Product NDC
82975-101
Requested package NDC
82975-101-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82975-10182975-101-01DDiscontinued by firm2026-10-23

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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 120 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c593b-c65b-62b5-e063-6294a90ac4c22025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c9167-638c-1e30-e063-6394a90a93742025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact identifier
application number: M020
20 Zinc Oxide Non-Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766e6c0-8976-509d-e063-6394a90af00f2025-12-15Exact identifier
application number: M020
20 Zinc Oxide Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766b00f-ceda-a6f9-e063-6294a90aff5d2025-12-15Exact identifier
application number: M020
Mattifying Skin PrimerTITANIUM DIOXIDE, ZINC OXIDESKIN MAVEN37662032-2842-1982-e063-6294a90a49a02025-12-15Exact identifier
application number: M020
Moisturizing Face and Body SPFZINC OXIDESKIN MAVEN376645ee-7ea8-e738-e063-6394a90a119b2025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC3985a298-fe0b-c296-e063-6294a90ab6c02025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC39856675-c110-a7a7-e063-6294a90ac6af2025-12-15Exact identifier
application number: M020
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3764f723-cc7a-2128-e063-6294a90ac8942025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC37656077-5185-817a-e063-6394a90adf5a2025-12-15Exact identifier
application number: M020
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact 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