Unscented Lip Balm

Manufacturer
Sierra Sage Herbs LLC
Effective date
2022-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:09

Label at a glance#

ProductUnscented Lip Balm
Active ingredientCALENDULA OFFICINALIS FLOWER
Label structure9 sections

Indications and uses

• 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 ª chapped and cracked lips

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 and 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 ª chapped and cracked lips

Keep our of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warning Section

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.

Storange and Handling

STORAGE AND HANDLING SECTION

Store at room temperature.

Dosage & Administration

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, Tocopherols (Vitamin E) Oil.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unscented Lip BalmUnscented 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
70994-405-072024-01-30C16284748780-11030e365-6f1b-111a-e063-dadaa90a10e2Unscented Liip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70994-405-07Unscented Lip Balm4.25 g in 1 TUBESALVE4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70994-405UNSCENTED LIP BALM (CALENDULA OFFICINALIS FLOWERS) SALVE [SIERRA SAGE HERBS LLC]1Legacy NDC, 1 package rows20220309_d943aa8d-24d7-3296-e053-2a95a90a3054.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70994-40570994-405-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
d943aa8d-24d8-3296-e053-2a95a90a3054d943aa8d-24d7-3296-e053-2a95a90a30542022-03-02WarningsExact identifier
spl id: d943aa8d-24d8-3296-e053-2a95a90a3054
spl set id: d943aa8d-24d7-3296-e053-2a95a90a3054

Reported adverse events (FAERS/openFDA)#

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