NIA 24 SPF 30

Product NDC
43115-123
11-digit product format
431150123
Labeler code
43115
Product ID
43115-123_2d90c660-1a00-7dc4-e063-6294a90abc18
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Niadyne Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-09
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
75; 50; 30; 26 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct43115-123EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43115-12343115-123-02EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43115-12343115-123-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
NIA 24 SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE75 mg/mL
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE26 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5c9d56f-48b4-4f0e-add6-f73268755b16Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
43115-123-012023-02-17NIA 24 SPF 30
43115-123-022023-02-17NIA 24 SPF 30
43115-123-012023-01-30NIA 24 SPF 30
43115-123-022023-01-30NIA 24 SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43115-123-01NIA 24 SPF 301 in 1 PACKAGELOTION110
43115-123-01NIA 24 SPF 3030 mL in 1 TUBELOTION3010
43115-123-02NIA 24 SPF 3075 mL in 1 TUBELOTION7510
43115-123-02NIA 24 SPF 301 in 1 PACKAGELOTION110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
HOMOSALATEACTIVE MOIETYV06SV4M95SNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
ARCTOSTAPHYLOS UVA-URSI LEAFINACTIVE INGREDIENT3M5V3D1X36NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RANIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))INACTIVE INGREDIENT59TL3WG5CONIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ5NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050BNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ENIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
LOWBUSH BLUEBERRYINACTIVE INGREDIENTG90PX41VP0NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
LYCIUM CHINENSIS FRUITINACTIVE INGREDIENTTG711Q7A1QNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
MANGIFERA INDICA SEED BUTTERINACTIVE INGREDIENT4OXD9M35X2NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
MYRISTYL NICOTINATEINACTIVE INGREDIENT8QWM6I035CNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
NUTMEGINACTIVE INGREDIENTAEE24M3MQ9NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ANIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
SOYBEANINACTIVE INGREDIENTL7HT8F1ZODNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
WATERINACTIVE INGREDIENT059QF0KO0RNIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43115-123NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC]10Current NDC, Legacy NDC, 4 package rows20250210_e5c9d56f-48b4-4f0e-add6-f73268755b16.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 89 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION236bdb53-d7a5-43a2-8a0c-bce4a5522e262026-01-05WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION05ffb157-5e28-4e94-866d-9e3371480d842026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CONCEALER N 1TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONeedf8065-8897-4773-9cbb-bab57d2dd04f2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CORRECTING VEIL n MENSULIZOLE, OCTINOXATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION15a258a0-61c3-4419-bcdb-a8197d5ae46f2026-01-05WarningsExact identifier
application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact identifier
application number: M020
Poolside Butter Screen SPF 30 Sunscreen ButterHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCae838725-79ab-4c17-905b-d4138ad6af1f2026-01-05WarningsExact identifier
application number: M020
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb98a9cec-3c48-4614-b091-4e59fa7d196e2026-01-05WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen Oil MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC5a9f8888-529d-40d7-9489-baa5ff657cb42026-01-05WarningsExact identifier
application number: M020
Yon-Ka 50 Mineral FluidZINC OXIDELaboratoire MULTALER Yon-Ka47a8c8b2-30ff-0d40-e063-6294a90ac4612026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE EOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION6d2f82d5-b3af-44af-b6b0-de96a4cd95fc2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
application number: M020
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAYAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATESHISEIDO AMERICAS CORPORATION4a16dbb7-e860-4aae-8e8b-67abbe8295bd2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43115-123-01431150123011 TUBE in 1 PACKAGE (43115-123-01) / 30 mL in 1 TUBE1 tube2017-12-190000-00-00NoNoCurrent
43115-123-02431150123021 TUBE in 1 PACKAGE (43115-123-02) / 75 mL in 1 TUBE1 tube2017-12-190000-00-00NoNoCurrent