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 29 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUMAVOBENZONE, HOMOSALATE, AND OCTISALATEInnisfree Corporation524264b8-d360-1d7b-e063-6394a90ab1152026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI)ZINC OXIDEIlia, Inc.b595bcc6-a1ab-25c9-e053-2995a90a87aa2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT)ZINC OXIDEIlia, Inc.b97f7fe9-c070-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE)ZINC OXIDEIlia, Inc.b959e3c3-ca92-ee41-e053-2a95a90a60642026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17 MIHO)ZINC OXIDEIlia, Inc.b595f875-b774-f847-e053-2995a90a28862026-05-21WarningsExact identifier
application number: M020
LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110COCTINOXATE, ZINC OXIDEBEL STAR S.A.526a8e50-b1de-47e5-e063-6394a90a3a292026-05-21WarningsExact identifier
application number: M020
Live Tinted Hueguard Skin TintZINC OXIDELive Tinted0ff39ab1-e8d3-cad9-e063-6394a90af0eb2026-05-21WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Quartz 001ZINC OXIDESunsolve MD Inc26a54f00-d84d-8fe3-e063-6394a90a03e82026-05-21WarningsExact identifier
application number: M020
Inde WildZINC OXIDEInde Wild01529c59-8806-6423-e063-6294a90a49e32026-05-21WarningsExact identifier
application number: M020
CARDON SPF and MOISTURIZERAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc52122434-6e6f-39fc-e063-6394a90a1fd02026-05-21WarningsExact identifier
application number: M020
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45OCTINOXATE AND ZINC OXIDEMerz North America, Inc62c822d9-c8ed-4b95-8d88-806295f5a9362026-05-20WarningsExact identifier
application number: M020
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
application number: M020
Stream2Sea SPF 50ZINC OXIDEStream2Sea5243f110-fe5b-946a-e063-6394a90add7e2026-05-20WarningsExact identifier
application number: M020
SP-FB0D-L0TNBarrierProtectionMineralSunscreenBARRIER PROTECTION MINERAL SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)50786950-1c31-e467-e063-6394a90a6fc82026-05-20WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
application number: M020
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30OCTINOXATE AND ZINC OXIDEMerz North America, Inc.e120a659-0dfc-42ca-8158-58e8a0b457e52026-05-20WarningsExact identifier
application number: M020
Evereden Cooling Mineral Sunstick SPF 30ZINC OXIDEEden Brands Inc.4af9e668-0d88-74ad-e063-6394a90a52432026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522addd5-9701-3234-e063-6294a90aaa9d2026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522b4aca-fe5b-dfe2-e063-6394a90ae5782026-05-19WarningsExact 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