FDA.reportPublic FDA data

Lipkist Lip Balm

Manufacturer
Arizona Sun Products
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:53:16

Label at a glance#

ProductArizona Sun Products Lipkist Lip Balm SPF 15
Active ingredientOXYBENZONE, OCTINOXATE
Label structure9 sections

Indications and uses

Provides mminimal sunburn protection. Higher SPF gives more sunburn protection

Dosage and administration

Use anytime and apply liberally to the lips 30 minutes before and during sun exposure. Reapply after swimming and exercise. Use on children under the age of six months only wih the advise of a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.50%, Oxybenzone 3.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Provides mminimal sunburn protection. Higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop and ask a doctor

OTC - STOP USE SECTION

if rash or irritation develops and lasts.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a poison control center right away.

Directions

INSTRUCTIONS FOR USE SECTION

Use anytime and apply liberally to the lips 30 minutes before and during sun exposure. Reapply after swimming and exercise. Use on children under the age of six months only wih the advise of a physician.

Other Information

OTHER SAFETY INFORMATION

Sun Alert: Limiting sun exposure, wearing protective clothing, and using suscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera) Extract, Cera Alba (Beeswax),Flavor, Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Styrene/Butadiene Copolymer, Paraffinum Liquidum, Propylparaben, Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-442-4786

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lipkistlipkist

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130711552600104GTIN-13: 0711552600104
EAN-13: 0711552600104
GTIN-12: 711552600104
UPC-A: 711552600104
GTIN storage (14 digits): 00711552600104		lipkist.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61973-401-102026-01-29C16284748780-149896155-a0f5-586f-e063-e6dba90add90Lipkist Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61973-401-09Arizona Sun Products Lipkist Lip Balm SPF 154.25 g in 1 TUBELIPSTICK4.254

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61973-40161973-401-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
OXYBENZONE95OOS7VE0YACTIB
WHITE WAX7G1J5DA97FIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
SAFFLOWER OIL65UEH262ISIACT
MINERAL OILT5L8T28FGPIACT
CASTOR OILD5340Y2I9GIACT
OCTINOXATE4Y5P7MUD51ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SUNFLOWER SEEDR9N3379M4ZIACT

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
Arizona Sun Products Lipkist Lip Balm SPF 15LIP BALMArizona Sun Products11fbcb81-2735-53c8-e063-6394a90ab0fa2026-04-09WarningsExact identifier
ndc (package): 61973-401-09
ndc (product): 61973-401
ndc11 (package): 61973040109
spl id: 4f0caf77-8710-9a90-e063-6294a90ae5eb
spl set id: 11fbcb81-2735-53c8-e063-6394a90ab0fa

Reported adverse events (FAERS/openFDA)#

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