FDA.reportPublic FDA data

NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN

Manufacturer
NIADYNE INC
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:58

Label at a glance#

ProductNIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Non-water resistant product. 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 tim...

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

TITANIUM DIOXIDE 7.064%

ZINC OXIDE 14.00%

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.
  • Non-water resistant product.
  • 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

Nicotinate, Octyldodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Aluminum Starch Octenylsuccinate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Alcohol, Magnesium Sulfate, Dimethiconol, Polysilicone-11, Caprylyl Glycol, Bisabolol, Tocopheryl Acetate, Aluminum Hydroxide, Alumina,
Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Benzotriazolyl Dodecyl p-Cresol, Disodium EDTA, Fragrance (Parfum)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4001653404_SunDamageMINERAL_SPF30_75ml_Carton_FNL_8.28.184001653404_SunDamageMINERAL_SPF30_75ml_Carton_FNL_8.28.18

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
95250459-30e4-45c1-b08a-993044f49109Product name220250805
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43115-101-752022-07-29C16284748780-1e4f33bdf-a3a0-d8a0-e053-dadaa90a6e4eNIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM SPF 30 100% MINERAL SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43115-101-75NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREENSPF 301 in 1 BOXLOTION12
43115-101-75NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREENSPF 3075 mL in 1 TUBELOTION752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43115-101NIA24 SUN DAMAGE DEFENSE BROAD SPECTRUM 100 PERCENT MINERAL SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [NIADYNE INC]2Legacy NDC, 2 package rows20181227_d564534d-fc46-4571-a030-5c1b0ce5d979.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43115-10143115-101-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MYRISTYL NICOTINATE8QWM6I035CIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
HEXYL LAURATE4CG9F9W01QIACT
STEARIC ACID4ELV7Z65APIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
CETYL ALCOHOL936JST6JCNIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
DIMETHICONOL (14000 CST)M2HW98ZA4VIACT
POLYSILICONE-15F8DRP5BB29IACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM OXIDELMI26O6933IACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
EDETATE DISODIUM7FLD91C86KIACT

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
781eced4-4af0-453a-a280-db1cf8f27228d564534d-fc46-4571-a030-5c1b0ce5d9792018-12-26WarningsExact identifier
spl id: 781eced4-4af0-453a-a280-db1cf8f27228
spl set id: d564534d-fc46-4571-a030-5c1b0ce5d979

Reported adverse events (FAERS/openFDA)#

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