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 firm2026-10-21
excluded packagepackage82975-10182975-101-01DDiscontinued by firm2026-10-21

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 166 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Cream FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.287aa255-4601-c5be-e063-6394a90a4d742025-11-07WarningsExact identifier
application number: M020
e l f Holy Hydration Face SPF 30 Sunscreen,AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc44a8028b-731d-4561-b2e3-ee9738ad8d302025-11-07WarningsExact identifier
application number: M020
e l f Sun Boss Gloss SPF 25 Sunscreen Its your MauveZINC OXIDEe.l.f. Cosmetics, Inc.bce21361-c92c-40ad-a373-db3b83b15b8a2025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer SunburstAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc49d912c7-259a-487d-a523-b14031bfaab62025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer SunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d2025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer SunbeamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.f818f524-0263-4f89-b4f3-4dd83d688e7e2025-11-07WarningsExact identifier
application number: M020
e.l.f Invisible Sunscreen SPF 35AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Incc2af5591-04df-4958-901e-dbe11698b8442025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush MuchZINC OXIDEe.l.f. Cosmetics, Inc.53d64042-f9ef-494d-a347-490c6a3c49b82025-11-07WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f cosmetics,Inc.547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d2025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my JamZINC OXIDEe.l.f. Cosmetics, Inc.b7d56015-4734-4ce4-b40d-64236df810e32025-11-07WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy KweenZINC OXIDEe.l.f. Cosmetics, Inc.4d9784b6-c54d-483d-a5ba-c557a05300ec2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOWZINC OXIDEIn The Pynk LLC13badac4-e310-9589-e063-6394a90ab06b2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOURZINC OXIDEIn The Pynk LLC13bb8426-27cd-fbc9-e063-6294a90a8bf82025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOUZINC OXIDEIn The Pynk LLC1365c6d8-64cb-3cb3-e063-6394a90a9d642025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 10wZINC OXIDEe.l.f. Cosmetics, Incc8a935e6-f7ac-4e3a-e053-2a95a90a877a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 11wZINC OXIDEe.l.f. Cosmetics, Incc8a94fb4-8752-587c-e053-2995a90a1e9a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 13wZINC OXIDEe.l.f. Cosmetics, Incc8a9bf6c-80cd-5884-e053-2a95a90a4a662025-11-07WarningsExact 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