Home NDC 43115-123 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 43115-123 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43115-123 43115-123-02 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43115-123 43115-123-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…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 Ingredient Strength HOMOSALATE 75 mg/mL OCTISALATE 50 mg/mL AVOBENZONE 30 mg/mL OCTOCRYLENE 26 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43115-123-01 NIA 24 SPF 30 1 in 1 PACKAGE LOTION 1 10 43115-123-01 NIA 24 SPF 30 30 mL in 1 TUBE LOTION 30 10 43115-123-02 NIA 24 SPF 30 75 mL in 1 TUBE LOTION 75 10 43115-123-02 NIA 24 SPF 30 1 in 1 PACKAGE LOTION 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 ARCTOSTAPHYLOS UVA-URSI LEAF INACTIVE INGREDIENT 3M5V3D1X36 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) INACTIVE INGREDIENT 59TL3WG5CO NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 CERAMIDE 2 INACTIVE INGREDIENT C04977SRJ5 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 CERAMIDE 3 INACTIVE INGREDIENT 4370DF050B NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 GLYCYRRHIZINATE DIPOTASSIUM INACTIVE INGREDIENT CA2Y0FE3FX NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 HYDROGENATED PALM GLYCERIDES INACTIVE INGREDIENT YCZ8EM144Q NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 LOWBUSH BLUEBERRY INACTIVE INGREDIENT G90PX41VP0 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 LYCIUM CHINENSIS FRUIT INACTIVE INGREDIENT TG711Q7A1Q NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 MANGIFERA INDICA SEED BUTTER INACTIVE INGREDIENT 4OXD9M35X2 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 MYRISTYL NICOTINATE INACTIVE INGREDIENT 8QWM6I035C NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 NUTMEG INACTIVE INGREDIENT AEE24M3MQ9 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 SODIUM POLYACRYLATE (2500000 MW) INACTIVE INGREDIENT 05I15JNI2J NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 SOYBEAN INACTIVE INGREDIENT L7HT8F1ZOD NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43115-123 NIA 24 SPF 30 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [NIADYNE INC] 10 Current NDC, Legacy NDC, 4 package rows 20250210_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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43115-123-01 43115012301 1 TUBE in 1 PACKAGE (43115-123-01) / 30 mL in 1 TUBE 1 tube 2017-12-19 0000-00-00 No No Current 43115-123-02 43115012302 1 TUBE in 1 PACKAGE (43115-123-02) / 75 mL in 1 TUBE 1 tube 2017-12-19 0000-00-00 No No Current