Renew Dimethicone Skin Protectant

Product NDC
61924-410
11-digit product format
619240410
Labeler code
61924
Product ID
61924-410_9c58cced-782d-baef-e053-2995a90a383c
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant
Dosage form
CREAM
Route
TOPICAL
Labeler
Dermarite Industries LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-15
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61924-410IInactivated by FDA2026-10-15
excluded packagepackage61924-41061924-410-04IInactivated by FDA2026-10-15
excluded packagepackage61924-41061924-410-05IInactivated 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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61924-410-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61924-410-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61924-410-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61924-410-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61924-410-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61924-410-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61924-410-048af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61924-410-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61924-410-04834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61924-410-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61924-410-041332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61924-410-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61924-410-04fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61924-410-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61924-410-0486f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61924-410-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61924-410-04bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61924-410-05bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-410-04Renew Dimethicone Skin Protectant113 g in 1 TUBECREAM1136
61924-410-05Renew Dimethicone Skin Protectant5 g in 1 PACKETCREAM56

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ORENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1ORENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Canola OilINACTIVE INGREDIENT331KBJ17RKRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27ERENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
CholecalciferolINACTIVE INGREDIENT1C6V77QF41RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Corn OilINACTIVE INGREDIENT8470G57WFMRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
EthylparabenINACTIVE INGREDIENT14255EXE39RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
IsobutylparabenINACTIVE INGREDIENT0QQJ25X58GRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
NiacinamideINACTIVE INGREDIENT25X51I8RD4RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Olive OilINACTIVE INGREDIENT6UYK2W1W1ERENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
PEG-100 StearateINACTIVE INGREDIENTYD01N1999RRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Pyridoxine HydrochlorideINACTIVE INGREDIENT68Y4CF58BVRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2
WaterINACTIVE INGREDIENT059QF0KO0RRENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-410RENEW DIMETHICONE SKIN PROTECTANT (SKIN PROTECTANT) CREAM [DERMARITE INDUSTRIES LLC]6Legacy NDC, 2 package rows20241208_ae82d2b7-eb86-4bbe-825c-f7d7cd7610ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-410-0461924041004113 g in 1 TUBE (61924-410-04) 113 g2012-03-150000-00-00NoNoCurrent
61924-410-05619240410055 g in 1 PACKET (61924-410-05) 5 g2012-03-150000-00-00NoNoCurrent