FDA.reportPublic FDA data

Wellcare Sunstick Lip Balm

Manufacturer
BAMKO, LLC
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:33:25

Label at a glance#

ProductWellcare Sunstick Sunscreen Stick
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sunexposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(Sunscreen Stick) Avobenzone 2.5mg  Octyl Methoxycinnamate 7.5mg  Octocrylene 10mg  OctyI Salicylate 5mg  (Lip Balm) Avobenzone 0. 5mg. Octyl Methoxycinnamate 5mg  Octocrylene 3  OctyI Salicylate 2.2mg 









Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use ony.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center righaway.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sunexposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha-Tocopherol Acetate, Bis-Diglyceryl Polyacyladipate-2, Coconut Oil, Ethylhexyl Palmitate, Hydrogenated Soybean Oil, Microcrystalline Wax, Polyisobutylene(2300 MW), Olive Oil, Silicon Dioxide, Stevioside, Synthetic Wax (1200 MW).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha-Tocopherol Acetate, Bis-Diglyceryl Polyacyladipate-2, Coconut Oil, Ethylhexyl Palmitate, Fragrance (3-(3,4-Methylenedioxyphenyl)-2-methylpropanal, Ethyl vanillin, Propylene glycol, Vanillin), Hydrogenated Soybean Oil, Microcrystalline Wax, Olive Oil, Polyisobutylene(2300 MW), Stevioside, Synthetic Wax (1200 MW).

Wellcare Sunstick - Lip Balm, 0.14oz/4g (83149-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Wellcare Sunstick - Sunscreen Stick, 0.07oz/2g (83149-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P1LP1L

P2LP2L

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
83149-000-00Wellcare Sunstick Lip Balm4 g in 1 TUBESTICK43
83149-001-00Wellcare Sunstick Sunscreen Stick2 g in 1 TUBESTICK23

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83149-00183149-001-00
83149-00083149-000-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
ETHYL VANILLINYC9ST449YJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
VANILLINCHI530446XIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
OLIVE OIL6UYK2W1W1EIACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
STEVIOSIDE0YON5MXJ9PIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
OLIVE OIL6UYK2W1W1EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEVIOSIDE0YON5MXJ9PIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

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
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier
ndc (package): 83149-000-00
ndc (package): 83149-001-00
ndc (product): 83149-000
ndc (product): 83149-001
ndc11 (package): 83149000000
ndc11 (package): 83149000100
spl id: 486eb626-f6c7-9f89-e063-6394a90a1b0c
spl set id: ef977575-7ef0-fc09-e053-2a95a90a8993

Reported adverse events (FAERS/openFDA)#

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