SkinDog

Product NDC
42657-111
11-digit product format
426570111
Labeler code
42657
Product ID
42657-111_d7589450-bec8-4796-bc91-aa096017870e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
SkinDog, LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-05
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2 g/56.7g; g/56.7g; g/56.7g; g/56.7g; g/56.7g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42657-111IInactivated by FDA2026-10-15
excluded packagepackage42657-11142657-111-01IInactivated by FDA2026-10-15

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42657-111-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42657-111-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42657-111-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42657-111-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42657-111-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42657-111-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42657-111-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42657-111-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42657-111-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42657-111-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42657-111-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42657-111-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42657-111-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42657-111-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42657-111-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42657-111-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42657-111-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42657-111-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42657-111-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42657-111-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42657-111-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42657-111-01110d247fa046…a55b01930146…

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
42657-111-012019-11-13C16284748780-197449f38-ba0b-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42657-111-01SkinDog56.7 g in 1 TUBELOTION56.75

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
HomosalateACTIVE INGREDIENTV06SV4M95SSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
OctisalateACTIVE INGREDIENT4X49Y0596WSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
OctocryleneACTIVE INGREDIENT5A68WGF6WMSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
OxybenzoneACTIVE INGREDIENT95OOS7VE0YSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
AvobenzoneACTIVE MOIETYG63QQF2NOXSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
HomosalateACTIVE MOIETYV06SV4M95SSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
OctisalateACTIVE MOIETY4X49Y0596WSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
OctocryleneACTIVE MOIETY5A68WGF6WMSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
OxybenzoneACTIVE MOIETY95OOS7VE0YSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
ALTHAEA OFFICINALIS ROOTINACTIVE INGREDIENTTRW2FUF47HSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
HEDERA HELIX LEAFINACTIVE INGREDIENTZP9XFG71A7SKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
SORBITOLINACTIVE INGREDIENT506T60A25RSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5
WaterINACTIVE INGREDIENT059QF0KO0RSKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42657-111SKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]5Legacy NDC, 1 package rows20120302_f63fe245-8396-477d-83af-66e5f4f7ceba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42657-111-014265701110156.7 g in 1 TUBE56.7 gHistorical