FDA.reportPublic FDA data

Sunscreen Lip Balm SPF 30 Cool Mint

Manufacturer
USRX
Effective date
2025-04-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:55

Label at a glance#

ProductSunscreen Lip Balm SPF 30 Cool Mint
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient SectionActive Ingredient Section

OTC - PURPOSE SECTION

Sunscreen

Purpose SectionPurpose Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions • Apply liberally and generously 15 minutes before sun exposure. • Reapply after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. • Children under 6 months: Ask a doctor.

Sun protective measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher, and other sun protection measures, including: • Limit time in the sun, especially from 10 am to 2 pm. • Wear long-sleeve shirts, pants, hats, and sunglasses.

WARNINGS SECTION

For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation occurs

INACTIVE INGREDIENT SECTION

Beeswax, Octyldodecanol, Butyloctyl Salicylate, Simmondsia Chinensis (Jojoba) Seed Oil, Octyldodecyl Neopentanoate, Punica Granatum Sterols, Caprylic/Capric Triglyceride, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate, Hydrogenated Castor Oil, Ricinus Communis (Castor) Seed Oil, Sodium Hyaluronate, Flavor / Aroma, Limonene

INDICATIONS & USAGE SECTION

When using this product keep out of eyes. Rinse with water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Principal Display PanelPackage Label Principal Display Panel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1235-1Sunscreen Lip Balm SPF 30 Cool Mint4.8 g in 1 TUBESTICK4.82
70809-1235-2Sunscreen Lip Balm SPF 30 Cool Mint1 in 1 BOXSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1235SUNSCREEN LIP BALM SPF 30 COOL MINT (AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%) STICK [USRX]2Current NDC, 2 package rows20250515_3271ab14-3bf5-a24f-e063-6294a90a59bc.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70809-123570809-1235-1, 70809-1235-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
OCTOCRYLENE5A68WGF6WMACTIB
BEESWAX2ZA36H0S2VIACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
OCTISALATE4X49Y0596WACTIB
OCTYLDODECANOL461N1O614YIACT
PUNICA GRANATUM STEROLSUKV92KC49TIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
SODIUM HYALURONATEYSE9PPT4THIACT
HOMOSALATEV06SV4M95SACTIB
PEPPERMINT OILAV092KU4JHIACT

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
Sunscreen Lip Balm SPF 30 Cool MintAVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%USRX3271ab14-3bf5-a24f-e063-6294a90a59bc2025-04-16WarningsExact identifier
ndc (package): 70809-1235-2
ndc (package): 70809-1235-1
ndc (product): 70809-1235
ndc11 (package): 70809123501
ndc11 (package): 70809123502
spl id: 32e678d4-d203-1ee5-e063-6394a90ac69b
spl set id: 3271ab14-3bf5-a24f-e063-6294a90a59bc

Reported adverse events (FAERS/openFDA)#

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