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

Fusion Water Magic by

Drug Labeling and Warnings

Fusion Water Magic by is a Otc medication manufactured, distributed, or labeled by ISDIN Corp., Laboratoris Feltor. 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 swallowed, get medical help or contact a Poison Control Center right away.

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

Other information

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

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

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

Fusion Water
MAGIC™

DAILY
PROTECTION

SPF 40 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 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-016
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
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
Sodium Hydroxide (UNII: 55X04QC32I)
Polysorbate 60 (UNII: CAL22UVI4M)
Water (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Caprylyl Glycol (UNII: 00YIU5438U)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
Physalis Pubescens Fruit Juice (UNII: GM2TDN9DZI)
Propanediol (UNII: 5965N8W85T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Tocopherol (UNII: R0ZB2556P8)
Hydrated Silica (UNII: Y6O7T4G8P9)
C20-22 Alkyl Phosphate (UNII: L4VKP0Y7RP)
C20-22 Alcohols (UNII: O4M0347C6A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
Hydroxyacetophenone (UNII: G1L3HT4CMH)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ACRYLIC ACID (UNII: J94PBK7X8S)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69494-016-01	1 in 1 CARTON	02/15/2025
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 69494-016-02	1 in 1 CARTON	02/15/2025
2		10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	03/01/2024

Labeler - ISDIN Corp. (079609155)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoris Feltor		464201441	MANUFACTURE(69494-016)