FDA.reportPublic FDA data

JUNGSAEMMOOL Essential Skin Nuder Cushion Medium

Product NDC
71261-033
11-digit product format
712610033
Labeler code
71261
Product ID
71261-033_4fa83ebe-eaf5-924a-e063-6294a90a6dfe
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
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
80c60ffa-69e0-4b31-bd0d-fc8ff9936ba0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71261-033-01JUNGSAEMMOOL Essential Skin Nuder Cushion Medium14 g in 1 CONTAINERCREAM142
71261-033-02JUNGSAEMMOOL Essential Skin Nuder Cushion Medium2 in 1 CARTONCREAM22
71261-033-03JUNGSAEMMOOL Essential Skin Nuder Cushion Medium1 in 1 CARTONCREAM12
71261-033-04JUNGSAEMMOOL Essential Skin Nuder Cushion Medium14 g in 1 POUCHCREAM142
71261-033-05JUNGSAEMMOOL Essential Skin Nuder Cushion Medium1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71261-033JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [JUNGSAEMMOOL BEAUTY CO., LTD.]1Current NDC, 5 package rows20240806_80c60ffa-69e0-4b31-bd0d-fc8ff9936ba0.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 121 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3765331e-ad4b-5661-e063-6294a90a7c202025-12-15Exact identifier
application number: M020
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
application number: M020
Face LoveZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d043a7-7269-469f-e063-6294a90a1a4d2025-12-15Exact identifier
application number: M020
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
application number: M020
Chem-Free Sunscreen Non-Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC3594d573-c680-62c9-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Chem Free Sunscreen Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC35948531-37ef-1fce-e063-6294a90ae79b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
application number: M020
Simply Protected Tinted Mineral SunscreenZINC OXIDEHealthy Skin & Body LLC380416b9-180a-3904-e063-6294a90a7bee2025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
application number: M020
Barrier Plus Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38038beb-d0f0-ced2-e063-6294a90ac4232025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC3764cbeb-55f5-4a9c-e063-6394a90a863d2025-12-15Exact identifier
application number: M020
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
application number: M020
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
application number: M020
Prime And Protect DewyZINC OXIDEKalon Skin Studio, LLC3593cefe-a08f-eb88-e063-6394a90aaff62025-12-15Exact identifier
application number: M020
GlowZINC OXIDEGODDESSLYNNEBODYANDSKIN37247365-33ee-563d-e063-6394a90a249e2025-12-15Exact identifier
application number: M020
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36d9d83b-7da5-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36da1a55-c076-cdd9-e063-6294a90ac97c2025-12-15Exact identifier
application number: M020
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71261-033-017126100330114 g in 1 CONTAINER14 gHistorical
71261-033-02712610033022 CONTAINER in 1 CARTON (71261-033-02) / 14 g in 1 CONTAINER (71261-033-01) 2 container2024-07-29NoNoCurrent
71261-033-03712610033031 CONTAINER in 1 CARTON (71261-033-03) / 14 g in 1 CONTAINER (71261-033-01) 1 container2026-04-17NoNoCurrent
71261-033-047126100330414 g in 1 POUCH14 gHistorical
71261-033-05712610033051 POUCH in 1 CARTON (71261-033-05) / 14 g in 1 POUCH (71261-033-04) 1 pouch2026-04-17NoNoCurrent