FDA.reportPublic FDA data

Lip Balm 4pc Kit

Manufacturer
Sierra Sage Herbs LLC
Effective date
2022-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:06:24

Label at a glance#

ProductLip Balm 4pc Kit
Active ingredientCALENDULA OFFICINALIS FLOWER, ZINC OXIDE
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 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.

■ 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 and Handling section

Store at room temperature.

Dosage & Administration Section

Apply as often as needed to affected area.

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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lip Balm 4pc KitLip Balm 4pc Kit

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
70994-40670994-406-12
70994-410
70994-407
70994-408
70994-409

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
OLIVE OIL6UYK2W1W1EIACT
ORANGE OILAKN3KSD11BIACT
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
ZINC OXIDESOI2LOH54ZACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT
LEMON OILI9GRO824LLIACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT
LEMON OILI9GRO824LLIACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
ORANGE OILAKN3KSD11BIACT
OLIVE OIL6UYK2W1W1EIACT
MENTHA PIPERITA79M2M2UDA9IACT
OLIVE OIL6UYK2W1W1EIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT

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
0e85a1ff-153f-187e-e063-6394a90a3b1ed96758d4-08a1-1bf3-e053-2995a90af1cf2024-01-09WarningsExact identifier
spl set id: d96758d4-08a1-1bf3-e053-2995a90af1cf

Reported adverse events (FAERS/openFDA)#

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