DOUBLE WEAR

Product NDC
11559-036
11-digit product format
115590036
Labeler code
11559
Product ID
11559-036_10a53da2-70ba-47d9-bbae-0f2b523e65aa
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
ESTEE LAUDER INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct11559-036DDiscontinued by firm2026-10-05
excluded packagepackage11559-03611559-036-01DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage11559-036-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11559-036-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11559-036-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11559-036-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11559-036-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11559-036-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11559-036-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11559-036-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11559-036-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11559-036-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11559-036-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11559-036-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
ascorbyl palmitateINACTIVE INGREDIENTQN83US2B0NDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
chromic oxideINACTIVE INGREDIENTX5Z09SU859DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
chromium hydroxide greenINACTIVE INGREDIENTRV8FT8XF5RDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
jojoba oilINACTIVE INGREDIENT724GKU717MDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
octyldodecanolINACTIVE INGREDIENT461N1O614YDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APDOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1
tocopherolINACTIVE INGREDIENTR0ZB2556P8DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]1