FDA.reportPublic FDA data

Cool Mint Lip Balm

Manufacturer
Spry Life LLC
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:35:51

Label at a glance#

ProductCool Mint Lip Balm
Active ingredientCALENDULA OFFICINALIS FLOWER
Label structure9 sections

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Purpose Section

OTC - PURPOSE SECTION

Skin Protectant

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

Indications & Usage

INDICATIONS & USAGE SECTION

■ temporarily helps protect and helps relieve chapped or cracked lips

■ helps protect from the drying effects of wind and cold weather

■ temporarily protects and helps relieve minor skin irritations due to

■ chafing ■ redness ■ windburn ■ sun exposure

Keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warnings Section

Warnings

For external use only.

■ Do not use on ■ deep wounds ■ animal bites ■ serious burns

■ Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days

■ When using this product keep out of eyes. rinse with water to remove.

Storage

STORAGE AND HANDLING SECTION

Store at room temperature.

Dosage & Administration Section

Apply as often as needed to affected area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Organic Olea Europaea (Olive) Fruit Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Cera Alba (Beeswax), Organic Cocos Nucifera (Coconut) Oil, Citrus Sinensis (Orange) Fruit Extract, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Mentha Piperita (Peppermint) Oil.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Green Goo Cool Mint Lip BalmGreen Goo Cool Mint Lip Balm

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70994-403-07Cool Mint Lip Balm4.25 g in 1 TUBESALVE4.257

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70994-40370994-403-07

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
YELLOW WAX2ZA36H0S2VIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
COCONUT OILQ9L0O73W7LIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
MENTHA PIPERITA79M2M2UDA9IACT

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
Cool Mint Lip BalmCALENDULA OFFICIALS FLOWERSSpry Life LLC48c18663-cf63-576b-e054-00144ff88e882025-12-15WarningsExact identifier
ndc (package): 70994-403-07
ndc (product): 70994-403
ndc11 (package): 70994040307
spl id: 4604ba05-aef9-a059-e063-6394a90aa26d
spl set id: 48c18663-cf63-576b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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