FDA.reportPublic FDA data

Prickly Pear 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 Prickly Pear Lip Balm SPF 15
Active ingredientOCTINOXATE, OXYBENZONE
Label structure9 sections

Indications and uses

Provides moderate 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 moderate 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 use and ask a doctor if

OTC - STOP USE SECTION

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), Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Styrene/Butadiene Copolymer, Opuntia Ficus-Indica (Prickly Pear) Fruit Extract, Paraffinum Liquidum, Prickly Pear Flavor, Propylparaben, Prunus Armeniaca (Apricot) Kernel Oil, Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Tocopheryl Acetate

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-442-4786

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61973-400-10Arizona Sun Prickly Pear Lip Balm SPF 15153 g in 1 CARTONLIPSTICK1534

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61973-40061973-400-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRICKLY PEAR FRUIT18V8PAQ629IACT
TOCOPHEROLR0ZB2556P8IACT
OPUNTIA FICUS-INDICA FRUIT JUICE5ZC110ZY2HIACT
PROPYLPARABENZ8IX2SC1OHIACT
OCTINOXATE4Y5P7MUD51ACTIB
SAFFLOWER OIL65UEH262ISIACT
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
CASTOR OILD5340Y2I9GIACT
SUNFLOWER SEEDR9N3379M4ZIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OXYBENZONE95OOS7VE0YACTIB
WHITE WAX7G1J5DA97FIACT
APRICOT KERNEL OIL54JB35T06AIACT

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 Prickly Pear Lip Balm SPF 15SUNSCREEN LIP BALMArizona Sun Products11e9cb25-6ff8-a121-e063-6394a90a849e2026-04-09WarningsExact identifier
ndc (package): 61973-400-10
ndc (product): 61973-400
ndc11 (package): 61973040010
spl id: 4f0be526-e00b-c7ef-e063-6394a90a7e27
spl set id: 11e9cb25-6ff8-a121-e063-6394a90a849e

Reported adverse events (FAERS/openFDA)#

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