FDA.reportPublic FDA data

Arizona Sun Products Cycleblok Lip Balm SPF 15

Product NDC
61973-404
11-digit product format
619730404
Labeler code
61973
Product ID
61973-404_4f0cadec-4361-a216-e063-6394a90a40fc
Type
HUMAN OTC DRUG
Nonproprietary name
Lip Balm
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Arizona Sun Products
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-22
Substance
OXYBENZONE; OCTINOXATE
Active strength
30; 75 mg/g; mg/g
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
Arizona Sun Products Cycleblok Lip Balm SPF 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE30 mg/g
OCTINOXATE75 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95OOS7VE0YInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11fd9aa5-dbd6-e5a7-e063-6394a90a3eacAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61973-404-102026-01-29C16284748780-149896155-a750-586f-e063-e6dba90add90Cycleblok Lipbalm Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61973-404-10Arizona Sun Products Cycleblok Lip Balm SPF 15153 g in 1 CARTONLIPSTICK1533
61973-404-09Arizona Sun Products Cycleblok Lip Balm SPF 154.25 g in 1 TUBELIPSTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61973-404ARIZONA SUN PRODUCTS CYCLEBLOK LIP BALM SPF 15 (LIP BALM) LIPSTICK [ARIZONA SUN PRODUCTS]1Current NDC, 1 package rows20240224_11fd9aa5-dbd6-e5a7-e063-6394a90a3eac.zip
61973-404ARIZONA SUN PRODUCTS CYCLEBLOK LIP BALM SPF 15 (LIP BALM) LIPSTICK [ARIZONA SUN PRODUCTS]1Current NDC, 1 package rows20240224_11fd8776-99f8-e5a4-e063-6394a90a2033.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 251 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d338ec2-dca0-e032-e063-6394a90a69aa2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752d79d-5d82-0367-e063-6394a90a4f1c2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d33888d-20b3-f912-e063-6394a90a25dc2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d3379ba-465c-a889-e063-6394a90aaf232024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a0-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0751b356-607f-f3cb-e063-6294a90a40922024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cace-1b3e-e063-6394a90afe5d2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION07530636-cd21-3022-e063-6394a90a89d62024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752753e-cac9-9166-e063-6394a90a4d8d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06ad3c09-9f1b-b25c-e063-6294a90aebe12024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c57ff5-7013-d35f-e063-6394a90a6ee22024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b29-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44de-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44ef-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a3-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b2b-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44cb-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b2b996-e02c-e40a-e063-6394a90aa0d92024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42d0-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61973-404-09619730404094.25 g in 1 TUBE (61973-404-09) 4.25 g2024-02-22NoNoCurrent
61973-404-1061973040410153 g in 1 CARTON (61973-404-10) 153 g2024-02-22NoNoCurrent