FDA.reportPublic FDA data

NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN

Manufacturer
NIADYNE INC
Effective date
2020-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:36:22

Label at a glance#

ProductNIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN SPF-30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen witha broad spectrum SPF 15 or higher and other sun protection measures, including: - Limit time in the sun, especially from...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Homosalate 7.5%
Octisalate 5%
Octocrylene 2.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse well with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen witha broad spectrum SPF 15 or higher and other sun protection measures, including:
    - Limit time in the sun, especially from 10 am – 2 pm.
    - Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water, Eau), Dipropylene Glycol, Myristyl Nicotinate, Polyester-8, Caprylyl Methicone, Cyclopentasiloxane, Glycine Soja (Soybean) Seed Extract, Ceramide NG, Ceramide NP, Lycium Chinense Fruit Extract, Vaccinum Angustifolium (Blueberry) Fruit Extract Arctostaphylos Uva Ursi Leaf Extract, Mangifera Indica (Mango) Seed Butter, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Sorbitan Sesquioleate, Cetyl Alcohol, Methyl Glucose Sesquistearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Butylene Glycol, Caprylyl Glycol, Sodium Acrylate/Sodium Acryloyidimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Fragrance (Parfum),
Polyacrylate-15, Polyacrylate -17, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Phenoxyethanol, Chlorphenesin, Xanthan Gum, Cyclohexasiloxane, Potassium Hydroxide, C11-15 Pareth-7, C11-15 Pareth-40, Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Sorbitan Oleate, Potassium Sorbate, Hexylene Glycol, Hydroxyisohexyl 3-cyclohexene carboxaldehyde

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4001523405_SunDamageDEFENSE_SPF30_Carton_FNL_8.23.184001523405_SunDamageDEFENSE_SPF30_Carton_FNL_8.23.18

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43115-102-752022-01-28C16284748780-1d6a99b39-817c-a426-e053-dadaa90af4c2NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM SPF 30 UVA/UVB SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43115-102-75NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREENSPF-3075 mL in 1 TUBELOTION754
43115-102-75NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREENSPF-301 in 1 BOXLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43115-102NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM UVA/UVB SUNSCREEN SPF-30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [NIADYNE INC]4Legacy NDC, 2 package rows20210101_ca676a93-662e-4f45-883b-f896e9533ca8.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43115-10243115-102-75

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
MYRISTYL NICOTINATE8QWM6I035CIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CYCLOMETHICONE 50THT5PCI0RIACT
SOYBEANL7HT8F1ZODIACT
CERAMIDE NGC04977SRJ5IACT
CERAMIDE NP4370DF050BIACT
LYCIUM CHINENSE FRUITTG711Q7A1QIACT
BLUEBERRY253RUG1X1AIACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CETYL ALCOHOL936JST6JCNIACT
METHYL GLUCOSE SESQUISTEARATEV1YW10H14DIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW)WR7H9IW2XXIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
CYCLOMETHICONE 6XHK3U310BAIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
C11-15 PARETH-7261HPE0IS3IACT
C11-15 PARETH-40L774F88277IACT
SODIUM LAURETH-12 SULFATE8M492LDU23IACT

Source Document#

Source XML

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
18fb048a-9c0e-4645-9c31-d5d9ccf8e0f9ca676a93-662e-4f45-883b-f896e9533ca82020-12-31WarningsExact identifier
spl id: 18fb048a-9c0e-4645-9c31-d5d9ccf8e0f9
spl set id: ca676a93-662e-4f45-883b-f896e9533ca8

Reported adverse events (FAERS/openFDA)#

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