ScarScreen

Product NDC
70089-100
11-digit product format
700890100
Labeler code
70089
Product ID
70089-100_1f82d7ca-4e2a-4550-bc7d-8803fd5c7745
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Natural Crest Laboratories Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-09-15
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
1 g/5mL
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 productproduct70089-100IInactivated by FDA2026-10-21
excluded packagepackage70089-10070089-100-11IInactivated by FDA2026-10-21

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 · 44 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70089-100-11IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70089-100-11IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70089-100-11IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70089-100-11IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70089-100-11IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70089-100-11IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70089-100-11IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70089-100-11IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70089-100-11IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70089-100-11IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70089-100-11IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70089-100-11IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70089-100-11IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70089-100-11IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70089-100-11IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70089-100-11IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70089-100-11IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70089-100-11IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70089-100-11IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70089-100-11IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70089-100-11IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70089-100-11EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70089-100-112020-01-31C16284748780-19d75b9d0-a5d6-f424-e053-dadaa90a57ceScarScreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70089-100-10ScarScreen60 mL in 1 TUBELOTION601
70089-100-11ScarScreen1 in 1 BOXLOTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
DIMETHICONE 200INACTIVE INGREDIENTRGS4T2AS00SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
METHYL GLUCETH-10INACTIVE INGREDIENTN0MWT4C7WHSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
METHYLCELLULOSE (4000 MPA.S)INACTIVE INGREDIENTMRJ667KA5ESCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70089-100SCARSCREEN (ZINC OXIDE) LOTION [NATURAL CREST LABORATORIES INC.]1Legacy NDC, 2 package rows20150922_cff1d197-23f0-457d-aa14-c84a57f07861.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70089-100-107008901001060 mL in 1 TUBE60 mlHistorical
70089-100-11700890100111 in 1 BOXHistorical