FDA.reportPublic FDA data

Fusion Water Magic

Product NDC
69494-016
11-digit product format
694940016
Labeler code
69494
Product ID
69494-016_8b0f9e3b-5166-4de7-b194-10e02391c196
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Homosalate, Octisalate, and Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
ISDIN Corp.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
90; 73; 45; 27 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fusion Water Magic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE90 mg/mL
HOMOSALATE73 mg/mL
OCTISALATE45 mg/mL
AVOBENZONE27 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4f91d5a-600a-4255-a6e1-e7e7197848c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69494-016-01Fusion Water Magic50 mL in 1 BOTTLE, PLASTICLOTION504
69494-016-01Fusion Water Magic1 in 1 CARTONLOTION14
69494-016-02Fusion Water Magic10 mL in 1 BOTTLE, PLASTICLOTION104
69494-016-02Fusion Water Magic1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69494-016FUSION WATER MAGIC (OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE) LOTION [ISDIN CORP.]1Current NDC, 4 package rows20250101_d4f91d5a-600a-4255-a6e1-e7e7197848c7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 96 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd46052d3-6f45-5f4d-e053-2995a90a87602025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc5dafd4-dfd4-d310-e053-2995a90a82a82025-12-31WarningsExact identifier
application number: M020
Coppertone EveryTone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Inc04c58384-fd82-f6d0-e063-6294a90a3ff12025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdort Inccc46b3a3-48f5-4593-e053-2995a90a87822025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport SPF 60 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb7304-789d-1f94-e063-6394a90a7e622025-12-31WarningsExact identifier
application number: M020
Coppertone Kids SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccbf9a785-f218-76fb-e053-2995a90a8e032025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60c2a38-ef92-0dff-e053-2995a90a47c42025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a5370-ec6f-42a7-e063-6394a90ac37c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd53e1253-f6a4-4f3d-e053-2a95a90a79ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Face SPF 60 Plus SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b36eb1-bffc-c31e-e063-6294a90a8eb32025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd47460a1-4768-ee44-e053-2a95a90adecf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd473e7ed-4a9f-76fe-e053-2995a90ab37d2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69494-016-01694940016011 BOTTLE, PLASTIC in 1 CARTON (69494-016-01) / 50 mL in 1 BOTTLE, PLASTIC2025-02-15NoNoCurrent
69494-016-02694940016021 BOTTLE, PLASTIC in 1 CARTON (69494-016-02) / 10 mL in 1 BOTTLE, PLASTIC2025-02-15NoNoCurrent