FDA.reportPublic FDA data

IPKN Moist and Firm Beauty Balm Light Medium

Product NDC
43526-129
11-digit product format
435260129
Labeler code
43526
Product ID
43526-129_2555c784-b00a-1912-e063-6394a90a091a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Inel Cosmetics Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-25
Substance
TITANIUM DIOXIDE
Active strength
65.1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
IPKN Moist and Firm Beauty Balm Light Medium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE65.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1af6184e-3dc4-4eb3-8d51-aca724473451Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43526-129-01IPKN Moist and Firm Beauty Balm Light Medium40 mL in 1 TUBECREAM401
43526-129-02IPKN Moist and Firm Beauty Balm Light Medium1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43526-129IPKN MOIST AND FIRM BEAUTY BALM LIGHT MEDIUM (TITANIUM DIOXIDE) CREAM [INEL COSMETICS CO., LTD.]1Current NDC, 2 package rows20241027_1af6184e-3dc4-4eb3-8d51-aca724473451.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 196 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earth Mama Tinted Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c455d29-df4e-f4d5-e063-6394a90a97ba2025-08-13WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen 1 OZZINC OXIDESun Bum, LLC3c483d04-8942-5269-e063-6294a90a38812025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c49c623-47c6-4dc9-e063-6294a90a00962025-08-13WarningsExact identifier
application number: M020
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dda967c-2d69-8948-e063-6294a90ad2a42025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9a9b8-41ba-123a-e063-6394a90a73cb2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dd9fe59-9e40-fd06-e063-6394a90a4ca22025-08-12WarningsExact identifier
application number: M020
Coola Anti-Aging Hand Cream SunscreenAVOBENZONE, OCTOCRYLENE, OCTISALATECOOLA LLC3c2fbf10-d68e-c601-e063-6294a90a09a32025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24ea340a-06cd-b085-e063-6394a90adff92025-08-12WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddad045-7703-ea7e-e063-6394a90a2a5a2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD0cf45fbf-b257-f16a-e063-6294a90a87942025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddb1f53-69dd-643a-e063-6394a90ad6002025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLC908c41fd-0496-4237-813b-1135e10ae0c52025-08-12WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLC74475fba-4cdd-4b27-8ea4-646f4016580c2025-08-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43526-129-014352601290140 mL in 1 TUBE40 mlHistorical
43526-129-02435260129021 TUBE in 1 CARTON (43526-129-02) / 40 mL in 1 TUBE (43526-129-01) 1 tube2024-10-25NoNoCurrent