Wellcare Sunstick Sunscreen Stick

Product NDC
83149-001
11-digit product format
831490001
Labeler code
83149
Product ID
83149-001_486eb626-f6c7-9f89-e063-6394a90a1b0c
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE
Dosage form
STICK
Route
TOPICAL
Labeler
BAMKO, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-15
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
25; 75; 50; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use ony. 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 a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center righaway.

Additional Listing Data#

Finished product
Yes
Brand name base
Wellcare Sunstick Sunscreen Stick
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE25 mg/g
OCTINOXATE75 mg/g
OCTOCRYLENE50 mg/g
OCTISALATE100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5A68WGF6WM, 4Y5P7MUD51, G63QQF2NOX, 4X49Y0596W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83149-001-00Wellcare Sunstick Sunscreen Stick2 g in 1 TUBESTICK23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83149-001WELLCARE SUNSTICK SUNSCREEN STICK (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE) STICK WELLCARE SUNSTICK LIP BALM (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE) STICK [BAMKO, LLC]2Current NDC, Legacy NDC, 1 package rows20231101_ef977575-7ef0-fc09-e053-2a95a90a8993.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83149-001-00831490001002 g in 1 TUBE (83149-001-00) 2 g2022-12-150000-00-00NoNoCurrent