FDA.reportPublic FDA data

JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep

Product NDC
71261-034
11-digit product format
712610034
Labeler code
71261
Product ID
71261-034_4fa8424e-ddae-27ee-e063-6394a90a8b62
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Jungsaemmool Beauty Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-29
Substance
TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE
Active strength
65.1; 67; 40 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE65.1 mg/g
OCTINOXATE67 mg/g
OCTISALATE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e18d601-700a-4c1c-a434-22582253bd95Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71261-034-01JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep14 g in 1 CONTAINERCREAM142
71261-034-02JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep2 in 1 CARTONCREAM22
71261-034-03JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep1 in 1 CARTONCREAM12
71261-034-04JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep14 g in 1 POUCHCREAM142
71261-034-05JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71261-034JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM DEEP (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [JUNGSAEMMOOL BEAUTY CO., LTD.]1Current NDC, 5 package rows20240806_0e18d601-700a-4c1c-a434-22582253bd95.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 120 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a94d6f-9b1c-1b26-e063-6394a90abe652025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a9a6ed-c446-c90c-e063-6294a90aaa742025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35a9ecd7-b416-0aab-e063-6294a90a323d2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35aa194a-9a2e-2b5f-e063-6294a90a98772025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596cd73-0811-32bc-e063-6394a90ad1322025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359782d7-6601-7d96-e063-6394a90af9dc2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f1b692-0b80-0536-e063-6294a90ae8632025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c593b-c65b-62b5-e063-6294a90ac4c22025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c9167-638c-1e30-e063-6394a90a93742025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71261-034-017126100340114 g in 1 CONTAINER14 gHistorical
71261-034-02712610034022 CONTAINER in 1 CARTON (71261-034-02) / 14 g in 1 CONTAINER (71261-034-01) 2 container2024-07-29NoNoCurrent
71261-034-03712610034031 CONTAINER in 1 CARTON (71261-034-03) / 14 g in 1 CONTAINER (71261-034-01) 1 container2026-04-17NoNoCurrent
71261-034-047126100340414 g in 1 POUCH14 gHistorical
71261-034-05712610034051 POUCH in 1 CARTON (71261-034-05) / 14 g in 1 POUCH (71261-034-04) 1 pouch2026-04-17NoNoCurrent