FDA.reportPublic FDA data

Fusion Mineral Body

Manufacturer
ISDIN Corp.
Effective date
2025-05-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:38:52

Label at a glance#

ProductFusion Mineral Body
Active ingredientZinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Shake well before use apply liberally 15 minutes before sun exposure Reapply: use a water-resistant sunscreen if swimming or sweating at least every 2 hours. Children under 6 months of age: Ask a doctor. 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 with broad spectrum SPF value of 15 or higher and other s...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

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 doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • apply liberally 15 minutes before sun exposure
  • Reapply:
    • use a water-resistant sunscreen if swimming or sweating
    • at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.
  • 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 with broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit your time in the sun, especially from 10 a.m.- 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Isoamyl Laurate, Jojoba Esters, Lecithin, Lysolecithin, Methylpropanediol, PEG-75 Stearate, Phenoxyethanol, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Sodium Hydroxide, Squalane, Steareth-20, Tetrasodium Glutamate Diacetate, Tocopherol, Water, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin.com

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISDIN
PHOTO

Fusion Mineral
BODY

BROAD SPECTRUM SPF 40

Ultralight protection and
hydration for all skin types

100% MINERAL
SUNSCREEN

3.4 FL OZ (100 mL)

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label
PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69494-014FUSION MINERAL BODY (ZINC OXIDE) LOTION [ISDIN CORP.]3Unmatched20250523_f1d4af38-577e-4861-87ae-a51215b6fa56.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69494-01469494-014-02, 69494-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
SOYBEAN LECITHIN1DI56QDM62IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
Hydrolyzed Jojoba Esters (Acid Form)UDR641JW8WIACT
MethylpropanediolN8F53B3R4RIACT
Caprylyl Glycol00YIU5438UIACT
Phenylpropanol0F897O3O4MIACT
Xanthan GumTTV12P4NEEIACT
Isoamyl LaurateM1SLX00M3MIACT
Hexylene GlycolKEH0A3F75JIACT
TocopherolR0ZB2556P8IACT
Cetyl Alcohol936JST6JCNIACT
Ethylhexylglycerin147D247K3PIACT
GlycerinPDC6A3C0OXIACT
Silicon DioxideETJ7Z6XBU4IACT
Water059QF0KO0RIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Ceteth-20I835H2IHHXIACT
Pullulan8ZQ0AYU1TTIACT
SqualaneGW89575KF9IACT
Steareth-20L0Q8IK9E08IACT
Cyclodextrins7E6SK9QDT8IACT

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
3e0652f7-5c83-4e50-95c4-d89502bcd8d5f1d4af38-577e-4861-87ae-a51215b6fa562025-05-20WarningsExact identifier
spl id: 3e0652f7-5c83-4e50-95c4-d89502bcd8d5
spl set id: f1d4af38-577e-4861-87ae-a51215b6fa56

Reported adverse events (FAERS/openFDA)#

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