FDA.reportPublic FDA data

SUNSCREEN LIP BALM

Manufacturer
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
Effective date
2024-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:24

Label at a glance#

ProductSUNSCREEN LIP BALM
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE, PETROLATUM
Label structure10 sections

Dosage and administration

apply liberally before sun exposure and as needed children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Petrolatum 30%

Purpose

OTC - PURPOSE SECTION

Sunscreen
Skin Protectant

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn
helps prevent and temporarily protect dry, chapped or
windburned lips

WarningS

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun
increases your risk of skin cancer and early skin aging.
This product has been shown only to help prevent
sunburn, not skin cancer or early skin aging.

For external use only.

OTC - WHEN USING SECTION

For external use only.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash or irritation develops and lasts.

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 right away.

Directions Of Safe Use

DESCRIPTION SECTION

apply liberally before sun exposure and as needed
children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

ynthetic Beeswax, Cetyl Alcohol,Paraffin, Mineral Oil,
Polyethylene, Flavor,Cocos Nucifera (Coconut) Oil, Lanolin,
Phenyl Trimethicone, Caprylic/Capric Triglyceride,Titanium
CI 77891, Isopropyl Myristate, Oleyl Alcohol,Tocopherol,
Isopropyl Lanolate, Helianthus Annuus (Sunflower) Seed
Oil, Stearic Acid,BHT, Tocopheryl Acetate,Theobroma Cacao
(Cocoa) Seed Butter, Aloe Barbadensis Leaf Extract,
Terminalia Ferdinandiana Fruit Extract, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive)
Fruit Oil.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84117-004-01SUNSCREEN LIP BALM5 g in 1 CANISTEROINTMENT51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84117-004SUNSCREEN LIP BALM OINTMENT [SHENZHEN HENGKAIFENG COMMERCE AND TRADE CO., LTD]11 package rows20240330_14b64f6d-abbe-34ef-e063-6394a90ad39f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84117-00484117-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
SYNTHETIC BEESWAX08MNR5YE2RIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UACTIB
CETYL ALCOHOL936JST6JCNIACT

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
14b64f6d-abbf-34ef-e063-6394a90ad39f14b64f6d-abbe-34ef-e063-6394a90ad39f2024-03-28WarningsExact identifier
spl id: 14b64f6d-abbf-34ef-e063-6394a90ad39f
spl set id: 14b64f6d-abbe-34ef-e063-6394a90ad39f

Reported adverse events (FAERS/openFDA)#

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