SOFT DERM INTENSIVE DEFENSE 8 SPF

Product NDC
75870-002
11-digit product format
758700002
Labeler code
75870
Product ID
75870-002_debf540c-ac04-4732-8ea1-9b1f1c2793e4
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-07-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
10 mL/50mL; mL/50mL
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 productproduct75870-002IInactivated by FDA2026-11-13
excluded packagepackage75870-00275870-002-02IInactivated by FDA2026-11-13

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 packagepackage75870-002-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75870-002-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75870-002-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage75870-002-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage75870-002-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage75870-002-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75870-002-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75870-002-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75870-002-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage75870-002-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage75870-002-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage75870-002-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage75870-002-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage75870-002-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage75870-002-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage75870-002-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage75870-002-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage75870-002-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage75870-002-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage75870-002-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage75870-002-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage75870-002-02110d247fa046…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
75870-002-022019-10-29C16284748780-1960f7f55-c572-8e05-e053-dbdaa90a074aSOFT DERM INTENSIVE DEFENSE 8 SPF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75870-002-01SOFT DERM INTENSIVE DEFENSE 8 SPF50 mL in 1 TUBECREAM504
75870-002-02SOFT DERM INTENSIVE DEFENSE 8 SPF1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
TITANIUMACTIVE MOIETYD1JT611TNESOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ALLANTOININACTIVE INGREDIENT344S277G0ZSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
CAPER BERRYINACTIVE INGREDIENT7G4C45EE8CSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
CAPSOSIPHON FULVESCENSINACTIVE INGREDIENTC59NK6GFJHSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
CETETH-20INACTIVE INGREDIENTI835H2IHHXSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
HYDROXYSTEARIC ACIDINACTIVE INGREDIENT933ANU3H2SSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
OCTYLDODECYL MYRISTATEINACTIVE INGREDIENTS013N99GR8SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
PEG-6 STEARATEINACTIVE INGREDIENT8LQC57C6B0SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW)INACTIVE INGREDIENTQ04O53779DSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
WATERINACTIVE INGREDIENT059QF0KO0RSOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75870-002SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]4Legacy NDC, 2 package rows20110615_a4b9580d-f44d-4fa6-ac59-95da3965326f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
75870-002-017587000020150 mL in 1 TUBE50 mlHistorical
75870-002-02758700002021 in 1 CARTONHistorical