FDA.reportPublic FDA data

Wellcare Sunstick

Manufacturer
Shenzhen Lantern Scicence Co.,Ltd. | LANTERN HEALTH&BEAUTY LAB INC. | Shenzhen Lantern Science Co.,Ltd.
Effective date
2022-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:45

Label at a glance#

ProductWellcare Sunstick 01
Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure14 sections

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 docto

Label contents#

Full prescribing information#

Drug Facts

DESCRIPTION SECTION

drug factsdrug facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(Sunscreen Stick)
Avobenzone 2.5mg Sunscreen
Octyl Methoxycinnamate 7.5mg Sunscreen
Octocrylene 10mg Sunscreen
OctyI Salicylate 5mg Sunscreen

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Directions

INDICATIONS & USAGE 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 docto

When using this product

OTC - WHEN USING SECTION

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center rightaway

Purpose

OTC - PURPOSE SECTION

Sunscreen

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Do not use

OTC - DO NOT USE SECTION

On damaged or broken skin.
When using this product keep out of eyes.
Rinse with water to remove

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sunlight

use

OTC - PURPOSE SECTION

Helps prevent sunburn.

warnings

WARNINGS SECTION

For external use only.

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 rightaway.

usage

INDICATIONS & USAGE 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 docto

package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package lablepackage lable

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54860-403-012024-01-30C16284748780-11030e365-08e7-111a-e063-dadaa90a10e2Wellcare Sunstick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54860-403-01Wellcare Sunstick016 g in 1 TUBEPASTE62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54860-403WELLCARE SUNSTICK 01 (AVOBENZONE, OCTYL METHOXYCINNAMATE, OCTOCRYLENE, OCTYI SALICYLATE) PASTE [SHENZHEN LANTERN SCICENCE CO.,LTD.]2Legacy NDC, 1 package rows20221122_edf2f110-9f9f-7c1c-e053-2995a90a7db6.zip

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
54860-40354860-403-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
VANILLINCHI530446XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ETHYL VANILLINYC9ST449YJIACT
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANALL65EG8H6PAIACT
STEVIOSIDE0YON5MXJ9PIACT
ETHYLHEXYL PALMITATE2865993309IACT
COCONUT OILQ9L0O73W7LIACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
AVOBENZONEG63QQF2NOXACTIB
HYDROGENATED SOYBEAN OILA2M91M918CIACT
OLIVE OIL6UYK2W1W1EIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OCTOCRYLENE5A68WGF6WMACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
edf2f110-9fa0-7c1c-e053-2995a90a7db6edf2f110-9f9f-7c1c-e053-2995a90a7db62022-11-20WarningsExact identifier
spl id: edf2f110-9fa0-7c1c-e053-2995a90a7db6
spl set id: edf2f110-9f9f-7c1c-e053-2995a90a7db6

Reported adverse events (FAERS/openFDA)#

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