NIA 24 SPF 30

Manufacturer
Niadyne Inc | Englewood Lab, Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:54:44

Label at a glance#

ProductNIA 24 SPF 30
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure19 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                 Purpose Homosalate 7.5%.................................Sunscreen Octisalate 5.0%...................................Sunscreen Avobenzone 3.0%................................Sunscreen Octocrylene 2.6%................................Sunscreen



OTC - PURPOSE SECTION

Uses  - for prevention of sunburn

WARNINGS SECTION

Warnings  For external use only.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - ASK DOCTOR SECTION

For children 6 months of age or under , consult a doctor prior to use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

If swallowed, get medical help or contact a poison control center right away.

PRECAUTIONS SECTION

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

DOSAGE & ADMINISTRATION SECTION

Directions  - Apply a dime sized amount in the morning on cleansed face and neck or over a moisturizer.  - Reapply as needed or after towel drying, swimming or perspiring.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water (Aqua/Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclomethicone, Glyceryl Stearate, Polyacrylate-15, Panthenol, Potassium Cetyl Phosphate, Butylene Glycol, Mangifera Indica (Mango) Seed Butter, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-17, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Seed Extract, Ceramide 2, Ceramide 3, Lycium Chinensis Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Sorbitan Sesquioleate, Polysorbate 80, Cetyl Alcohol, Tocopheryl Acetate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Myristica Fragrans (Nutmeg) Kernel Extract.

DESCRIPTION SECTION

Prevention Now Starts From Within.  The benefits of NIA 24TM help to prevent, repair and fight the visible signs of sun damage.  Skin Cancer Foundation Facts*:  - In our lifetime, 1 in 5 Americans will be victims of skin cancer.  - More than 90% of all skin cancers are preventable--- caused by sun exposure.  - The risk of melanoma has doubled in the past decade. It is responsible for 75% of all skin cancer-related deaths.  *These facts have been provided by the Skin Cancer Foundation.   - Improve the appearance of sun damage, hyperpigmentation and brown spots.  - Reduce the appearance of fine lines and wrinkle.  - Improve skin tone, texture and firmness.  - See stronger skin with a better self-defense against visible signs of sun damage and moisture loss.  Physician Recommended Allergy Tested  Fragrace, Color and Dye Free Non-Comedogenic.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIA 24  Niacin-Powered Skin Therapy  Sun Damage Prevention UVA/UVB  Sunscreen  Micro Nutrient Deliver: NIACHI  SPF 30  PA +++  5% Pro-Niacin  Patented Formula  For Moderate to Severs Sun Demage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Active Ingredients: Homosalate (7.5%), Octisalate (5.0%), Avobenzone (3.0%), Octocrylene (2.6%).  Uses  - for prevention of sunburn  Warnings  For external use only.When using this product, keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash or irritation develops and lasts.For children 6 months of age or under , consult a doctor prior to use.Keep out of reach of children.If swallowed, get medical help or contact a poison control center right away.UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.  e 30mL/1 FLUID OZ.  Covered by US Patents  6337065, 6552050, 6464992  NIADYNE, INC., Raieigh, NC 27609/BIORUS sprl, 2 rue Rene Descartes, B-7000 Mons, Belgium  866-NIADYNE (642-3963)  www.NIA24.com  Made in the USA  12M

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PreDamage  PostDamage UnDamage NIA24  Niacin Powered Skin Therapy  For Moderate Severe Sun Damage   PA +++  Sun Damage Prevention  UVA(aging)/UVB(burning) Sunscreen  MicroNutrient Delivery: NIACIN  SPF 30  PA+++  5% Pro-Niacin  Patented Formula  A lightweight, non-greasy lotion with SPF 30 and PA+++ that absorbs instantly into skin. Formulated with powerful ingredients that provide UVA (aging rays) and UVB (burning rays) protection from sun damage while helping to repair the skin barrier.  - Continuous, deep delivery of Pro-Niacin strengthens the skin barrier.  - Pro-Niacin is clinically shown to visibly improve skin tone, texture and hyperpigmentation.  - Broad spectrum protection (UVA/UVB) with the highest PA rating, helps defend skin against free radical attack that weakens and ages the skin.  - Mango butter provides balanced moisturization without leaving excess.  - Ceramides promote healthy, vibrant skin.  - Antioxidants protect skin from oxidative stress.  RECOMMENDED  SKIN CANCER FOUNDATION DAILY USE * These facts have been provided by the Skin Cancer Foundation  e 75mL/2.5 FLUID OZ  0141A1  EXP:01/2013  8  51203  00073  7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Covered by US Patents  6337065, 6552050, 6464992  NIADYNE, INC., Raieigh, NC 27609/BIORUS sprl, 2 rue Rene Descartes, B-7000 Mons, Belgium  For all consumer inquiries, please call 866-NIADYNE (642-3963)  www.NIA24.com  Made in the USA  12M  NIA24 NIA24 NIA24 NIA24 NIA24 NIA24 NIA24 NIA24 NIA24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIA24 Tube 1NIA24 Tube 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIA24 Tube 2NIA24 Tube 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIA24 Outer 1NIA24 Outer 1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43115-123-012023-02-17C16284748780-1f386c64a-3fed-0266-e053-dadaa90a7c1aNIA 24 SPF 30
43115-123-022023-02-17C16284748780-1f386c64a-3fed-0266-e053-dadaa90a7c1aNIA 24 SPF 30
43115-123-012023-01-30C16284748780-1f386c64a-3fed-0266-e053-dadaa90a7c1aNIA 24 SPF 30
43115-123-022023-01-30C16284748780-1f386c64a-3fed-0266-e053-dadaa90a7c1aNIA 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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
ARCTOSTAPHYLOS UVA-URSI LEAFINACTIVE INGREDIENT3M5V3D1X361
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))INACTIVE INGREDIENT59TL3WG5CO1
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ51
CERAMIDE 3INACTIVE INGREDIENT4370DF050B1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX1
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144Q1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
LOWBUSH BLUEBERRYINACTIVE INGREDIENTG90PX41VP01
LYCIUM CHINENSIS FRUITINACTIVE INGREDIENTTG711Q7A1Q1
MANGIFERA INDICA SEED BUTTERINACTIVE INGREDIENT4OXD9M35X21
MYRISTYL NICOTINATEINACTIVE INGREDIENT8QWM6I035C1
NUTMEGINACTIVE INGREDIENTAEE24M3MQ91
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138P1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2J1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A1
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43115-12343115-123-01, 43115-123-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii+route
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
9 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TGEL / TOPICAL3 mgExact identifier — unii+route
12 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii+route
12 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii+route
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
9 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODEMULSION / TOPICAL3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
9 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
9 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TGEL / TOPICAL3 mgExact identifier — unii+route
12 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii+route
12 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODEMULSION / TOPICAL3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODEMULSION / TOPICAL3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TGEL / TOPICAL3 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii+route
3 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIA 24 SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENENiadyne Ince5c9d56f-48b4-4f0e-add6-f73268755b162025-02-07WarningsExact identifier
ndc (package): 43115-123-02
ndc (package): 43115-123-01
ndc (product): 43115-123
ndc11 (package): 43115012302
ndc11 (package): 43115012301
spl id: 2d90c660-1a00-7dc4-e063-6294a90abc18
spl set id: e5c9d56f-48b4-4f0e-add6-f73268755b16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.