FDA.reportPublic FDA data

Kiss-on Lip Balm

Manufacturer
Sierra Sage Herbs LLC
Effective date
2017-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:35

Label at a glance#

ProductKiss-on 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) Flowers 1X (HPUS)

Indications & Usage

INDICATIONS & USAGE SECTION

• temporarily 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 • chaffing • redness • windburn • sun exposure
• temporarily helps moisturize • chapped and cracked lips

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.

• Don’t use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.

• Stop using and ask a doctor if rash or irritation occurs.

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 Beeswax (Cera alba), Organic Cocos nucifera (Coconut) Oil, Organic Jojoba (Simmondsia Chinensis) Oil, Organic Helianthus annuus (Sunflower) Oil, Organic Olive (Olea europaea) Oil, Non-GMO (100% Sunflower) Mixed Tocopherols (Vitamin E) Oil, Vanilla Absolute Extract, Cinnamon Bark Essential Oil, Coconut Flavor.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kiss-on Lip BalmKiss-on Lip Balm

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70994-404-122020-01-31C16284748780-19d75b9d0-d8be-f424-e053-dadaa90a57ceKiss-on Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70994-404-07Kiss-on Lip Balm4.25 g in 1 TUBESALVE4.251
70994-404-12Kiss-on Lip Balm1 in 1 BOXSALVE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70994-404KISS-ON LIP BALM (CALENDULA OFFICIALS FLOWERS) SALVE [SIERRA SAGE HERBS LLC]1Legacy NDC, 2 package rows20170218_48c1c11d-292e-5e48-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70994-40470994-404-07, 70994-404-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
COCONUT OILQ9L0O73W7LIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
COCONUT3RT3536DHYIACT
CINNAMON BARK OILXE54U569ECIACT
VANILLAQ74T35078HIACT

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
48c1c11d-292f-5e48-e054-00144ff8d46c48c1c11d-292e-5e48-e054-00144ff8d46c2017-02-17WarningsExact identifier
spl id: 48c1c11d-292f-5e48-e054-00144ff8d46c
spl set id: 48c1c11d-292e-5e48-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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