FITISH SPF 50 FACE

Product NDC
84417-002
11-digit product format
844170002
Labeler code
84417
Product ID
84417-002_569ce846-37d3-9a7d-e063-6394a90a6309
Type
HUMAN OTC DRUG
Nonproprietary name
FITISH SPF 50 FACE
Dosage form
STICK
Route
CUTANEOUS
Labeler
Fitish Holdings, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-26
Substance
OCTINOXATE; OCTOCRYLENE; OCTISALATE
Active strength
7.5; 8; 5 g/100g; g/100g; g/100g
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
FITISH SPF 50 FACE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100g
OCTOCRYLENE8 g/100g
OCTISALATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c44a572-59e6-c3c5-e063-6394a90a0e24Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84417-002-01FITISH SPF 50 FACE50 g in 1 BOTTLESTICK502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84417-002FITISH SPF 50 FACE STICK [FITISH HOLDINGS, LLC]2Current NDC, 1 package rows20240817_1c44a572-59e6-c3c5-e063-6394a90a0e24.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FITISH SPF 50 FACEFITISH SPF 50 FACEFitish Holdings, LLC1c44a572-59e6-c3c5-e063-6394a90a0e242026-07-14WarningsExact identifier
ndc (product): 84417-002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84417-002-018441700020150 g in 1 BOTTLE (84417-002-01) 50 g2024-06-26NoNoCurrent