MedPath

Fusion Water Magic

Fusion Water Magic™

Approved
Approval ID

d4f91d5a-600a-4255-a6e1-e7e7197848c7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 21, 2025

Manufacturers
FDA

ISDIN Corp.

DUNS: 079609155

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Octocrylene, Homosalate, Octisalate, and Avobenzone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69494-016
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octocrylene, Homosalate, Octisalate, and Avobenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 21, 2025
FDA Product Classification

INGREDIENTS (35)

OctocryleneActive
Quantity: 90 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
HomosalateActive
Quantity: 73 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OctisalateActive
Quantity: 45 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
Lauryl PEG/PPG-18/18 MethiconeInactive
Code: ZJ5S27D9NX
Classification: IACT
AvobenzoneActive
Quantity: 27 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
Butyloctyl SalicylateInactive
Code: 2EH13UN8D3
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PORPHYRIDIUM PURPUREUMInactive
Code: K2P8K2558N
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
BETASIZOFIRANInactive
Code: 2X51AD1X3T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
BEHENYL ACRYLATE POLYMERInactive
Code: D64PM5UT4U
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
Caprylyl GlycolInactive
Code: 00YIU5438U
Classification: IACT
TERT-BUTYL ALCOHOLInactive
Code: MD83SFE959
Classification: IACT
Physalis Pubescens Fruit JuiceInactive
Code: GM2TDN9DZI
Classification: IACT
PropanediolInactive
Code: 5965N8W85T
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TocopherolInactive
Code: R0ZB2556P8
Classification: IACT
Hydrated SilicaInactive
Code: Y6O7T4G8P9
Classification: IACT
C20-22 Alkyl PhosphateInactive
Code: L4VKP0Y7RP
Classification: IACT
C20-22 AlcoholsInactive
Code: O4M0347C6A
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
HydroxyacetophenoneInactive
Code: G1L3HT4CMH
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Inactive
Code: Q7UI015FF9
Classification: IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMERInactive
Code: 035MV9S1C3
Classification: IACT
ACRYLIC ACIDInactive
Code: J94PBK7X8S
Classification: IACT
TETRASODIUM GLUTAMATE DIACETATEInactive
Code: 5EHL50I4MY
Classification: IACT
Potassium Cetyl PhosphateInactive
Code: 03KCY6P7UT
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/21/2025

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

ISDIN

Fusion Water
MAGIC™

DAILY
PROTECTION

SPF 40 BROAD SPECTRUM
DAILY USE SUNSCREEN
WITH MEDITERRANEAN ALGAE
1.7 FL OZ (50 mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/21/2025

Uses

  • helps prevent sunburn
  • If used as directed with other sun protection measures (seeDirections) decreases the risk of skin cancer and early skin aging caused by the sun

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/21/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/21/2025

Active Ingredients

Purpose

Octocrylene 9%

Sunscreen

Homosalate 7.3%

Sunscreen

Octisalate 4.5%

Sunscreen

Avobenzone 2.7%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/21/2025

Warnings

*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 swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/21/2025

Directions

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: ask a doctor *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-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/21/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/21/2025

Inactive Ingredients

Water, Dimethicone, Silica, Butyloctyl Salicylate, Propanediol, Lauryl PEG/PPG-18/18 Methicone, Poly C10-30 Alkyl Acrylate, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Hydroxyacetophenone, Potassium Cetyl Phosphate, VP/Eicosene Copolymer, Polysorbate 60, Glycerin, Caprylyl Glycol, Tocopheryl Acetate, Polyacrylate Crosspolymer-6, Styrene/Acrylates Copolymer, Tetrasodium Glutamate Diacetate, Fragrance, Hydrated Silica, Sclerotium Gum, Sodium Hyaluronate, Xanthan Gum, Porphyridium Cruentum Extract, Caprylic/Capric Triglyceride, Physalis Pubescens Fruit Juice, Sodium Hydroxide, T-Butyl Alcohol, Tocopherol, Citric Acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/21/2025

Questions or comments?

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

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