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 36 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
White Mint SPF 15 Broad Spectrum Lip BalmWHITE MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff8c38-94f1-f589-e063-6294a90a5ba82026-05-04WarningsExact identifier
application number: M020
Surface Sun SPF 50 MineralZINC OXIDESurface Products Corpcabaf7e1-b940-4d6e-b21b-d99c3a4047a72026-05-04WarningsExact identifier
application number: M020
SPF 50 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp503d6b48-3516-4264-9fe8-71a9939669fe2026-05-04WarningsExact identifier
application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water ResistanceZINC OXIDESurface Products Corp02b770cf-7351-444b-b2c8-ad112e9bea3e2026-05-04WarningsExact identifier
application number: M020
SPF 30 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corpd13c9e6e-a5da-4691-8792-9d6025e166d72026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
application number: M020
OBGE PORE-ZERO Oil CONTROL SUN StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAdapt Inc.67209e46-1b7a-42df-b31f-fcb3cefbd7e12026-05-03WarningsExact identifier
application number: M020
EquateOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWALMART INC2617e5bc-27a2-f187-e063-6394a90a69802026-05-03WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun CreamZINC OXIDETHANK YOU FARMER CO., LTD20a44597-3d44-f0ea-e063-6294a90a903d2026-05-03WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.4df3e90e-98a0-edbf-e063-6394a90ae3c92026-05-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
application number: M020
EXTREME PROTECT SPF 30OCTINOXATE, ZINC OXIDESCIENCE OF SKINCARE LLCecc4d304-e7e2-45b6-b9b2-2c64d36308602026-05-01WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 SunscreenZINC OXIDEObagi Cosmeceuticals LLC54a3f855-48de-4ae0-b1f0-e957398530652026-05-01WarningsExact identifier
application number: M020
MEDICUBE PDRN HYDRATING UV SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLEAPR US INC50a73981-985a-0a70-e063-6394a90a89cf2026-04-30WarningsExact identifier
application number: M020
Sky and Sol Body SunscreenNON- NANO ZINC OXIDEDelta Ecommerce LLC2ddaa628-0e81-c8a7-e063-6394a90a84f42026-04-30WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
application number: M020
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact 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