FUSION WATER MAGIC- octocrylene, homosalate, octisalate, and avobenzone solution 
ISDIN Corp.

----------

Fusion Water™ Magic

Drug Facts

Active IngredientsPurpose
Octocrylene 9%Sunscreen
Homosalate 7.3%Sunscreen
Octisalate 4.5%Sunscreen
Avobenzone 2.7%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.

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

Directions

  • shake before use
  • 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 of age: ask a doctor.

Other information

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

Inactive Ingredients

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

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

FusionWater™
MAGiC

SPF 30 BROAD SPECTRUM
DAILY USE SUNSCREEN
WITH MEDITERRANEAN ALGAE

1.7 FL OZ (50 mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
FUSION WATER MAGIC 
octocrylene, homosalate, octisalate, and avobenzone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69494-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene90 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate73 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate45 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Propanediol (UNII: 5965N8W85T)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Hydroxyacetophenone (UNII: G1L3HT4CMH)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Glycerin (UNII: PDC6A3C0OX)  
Caprylyl Glycol (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Xanthan Gum (UNII: TTV12P4NEE)  
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
Physalis Pubescens Fruit Juice (UNII: GM2TDN9DZI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
Tocopherol (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69494-010-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/202304/30/2024
2NDC:69494-010-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/202304/30/2024
3NDC:69494-010-0710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/202304/30/2024
4NDC:69494-010-032 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/202304/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02012/15/202304/30/2024
Labeler - ISDIN Corp. (079609155)

Revised: 5/2024
Document Id: fe7b82d4-a7f8-43b3-9586-a22cf154e976
Set id: 1b7ddac8-9001-4ba8-9feb-95f15069b0b9
Version: 2
Effective Time: 20240501
 
ISDIN Corp.