FUSION WATER MAGIC- octocrylene, homosalate, octisalate, and avobenzone solution

Fusion Water Magic by

Drug Labeling and Warnings

Fusion Water Magic by is a Otc medication manufactured, distributed, or labeled by ISDIN Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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)

INGREDIENTS AND APPEARANCE

FUSION WATER MAGIC 
octocrylene, homosalate, octisalate, and avobenzone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	90 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	73 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	45 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69494-010-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2023
2	NDC: 69494-010-02	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2023
3	NDC: 69494-010-07	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2023
4	NDC: 69494-010-03	2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	12/15/2023

Labeler - ISDIN Corp. (079609155)