FDA.reportPublic FDA data

Fusion Mineral Facial

Manufacturer
ISDIN Corp.
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:24:53

Label at a glance#

ProductFusion Mineral Facial
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

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 the 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 time in the sun, especially f...

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.

Warning

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

  • 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 the 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 time in the sun, especially from 10 a.m.- 2 p.m.
    • wear long- sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: 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

Allantoin, Bisabolol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate, Helianthus Annuus (Sunflower) Extract, Jojoba Esters, Lecithin, Methylheptyl Isostearate, Methylpropanediol, Niacinamide, Nylon-12, Oryza Sativa (Rice) Bran Extract, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Chloride, Sodium Hydroxide, Tetrasodium Glutamate Diacetate, Tocopherol, Tridecyl Salicylate, Water

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 - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISDIN
PHOTO

Fusion Mineral
FACIAL

BROAD SPECTRUM SPF 40

Ultralight protection and
hydration for all skin types

100% MINERAL
SUNSCREEN

1.7 FL OZ (50 mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69494-01569494-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
Jojoba Oil724GKU717MIACT
MethylpropanediolN8F53B3R4RIACT
Caprylyl Glycol00YIU5438UIACT
Phenylpropanol0F897O3O4MIACT
Oryza Sativa Whole84IVV0906ZIACT
Tridecyl SalicylateAZQ08K38Z1IACT
Coco-Caprylate4828G836N6IACT
TocopherolR0ZB2556P8IACT
Nylon-12446U8J075BIACT
Helianthus Annuus Flowering TopBKJ0J3D1BPIACT
Methylheptyl Isostearate981F40Q9FFIACT
Silicon DioxideETJ7Z6XBU4IACT
Water059QF0KO0RIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
Allantoin344S277G0ZIACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Salvia Rosmarinus FlowerNR1A27F29OIACT
Sodium Hydroxide55X04QC32IIACT
Niacinamide25X51I8RD4IACT
Propanediol5965N8W85TIACT
Tetrasodium Glutamate Diacetate5EHL50I4MYIACT
Sodium Chloride451W47IQ8XIACT
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate687U3PEB2YIACT

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
eaf13437-a33f-4af9-9807-6a8fe618bb7b2824b9e1-184b-4f71-b482-dceeebb7fa8d2024-03-15WarningsExact identifier
spl set id: 2824b9e1-184b-4f71-b482-dceeebb7fa8d

Reported adverse events (FAERS/openFDA)#

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