Fusion Mineral Facial by ISDIN Corp. Fusion Mineral Facial

Drug Details [pdf]

FUSION MINERAL FACIAL- zinc oxide lotion
ISDIN Corp.

----------

Fusion Mineral Facial

Drug Facts

Active ingredient

Zinc Oxide 12%

Purpose

Sunscreen

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.

Warning

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask doctor if rash occurs.

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

Directions

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

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

Inactive ingredients

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?

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

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

FUSION MINERAL FACIAL
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
Jojoba Oil (UNII: 724GKU717M)
Methylpropanediol (UNII: N8F53B3R4R)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenylpropanol (UNII: 0F897O3O4M)
Oryza Sativa Whole (UNII: 84IVV0906Z)
Tridecyl Salicylate (UNII: AZQ08K38Z1)
Coco-Caprylate (UNII: 4828G836N6)
Tocopherol (UNII: R0ZB2556P8)
Nylon-12 (UNII: 446U8J075B)
Helianthus Annuus Flowering Top (UNII: BKJ0J3D1BP)
Methylheptyl Isostearate (UNII: 981F40Q9FF)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Water (UNII: 059QF0KO0R)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
Allantoin (UNII: 344S277G0Z)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Salvia Rosmarinus Flower (UNII: NR1A27F29O)
Sodium Hydroxide (UNII: 55X04QC32I)
Niacinamide (UNII: 25X51I8RD4)
Propanediol (UNII: 5965N8W85T)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Sodium Chloride (UNII: 451W47IQ8X)
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate (UNII: 687U3PEB2Y)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69494-015-01	1 in 1 CARTON	09/15/2023	03/14/2024
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	09/15/2023	03/14/2024

Labeler - ISDIN Corp. (079609155)

Revised: 3/2024

Document Id: eaf13437-a33f-4af9-9807-6a8fe618bb7b

Set id: 2824b9e1-184b-4f71-b482-dceeebb7fa8d

Version: 3

Effective Time: 20240315