Lip Balm 4pc Kit by Sierra Sage Herbs LLC Lip Balm 4pc Kit

Lip Balm 4pc Kit by

Drug Labeling and Warnings

Lip Balm 4pc Kit by is a Homeopathic medication manufactured, distributed, or labeled by Sierra Sage Herbs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIP BALM 4PC KIT- calendula officinalis flower 
Spry Life LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Lip Balm 4pc Kit

Purpose Section

Skin Protectant

Active Ingredients

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

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

Lip Balm 4pc Kit

LIP BALM 4PC KIT 
calendula officinalis flower kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70994-406
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70994-406-121 in 1 BOX; Type 0: Not a Combination Product03/04/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 4   in 3 
Part 2 4   in 2 
Part 3 4   in 4 
Part 4
Part 1 of 4
CITRUS ZEST LIP BALM 
calendula officinalis flower salve
Product Information
Item Code (Source)NDC: 70994-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
LEMON OIL (UNII: I9GRO824LL)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
ORANGE OIL (UNII: AKN3KSD11B)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/04/2022
Part 2 of 4
SWEET HONEY LIP BALM 
zinc oxide, calendula officinalis flower salve
Product Information
Item Code (Source)NDC: 70994-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.6 g  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
ORANGE OIL (UNII: AKN3KSD11B)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
LEMON OIL (UNII: I9GRO824LL)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/04/2022
Part 3 of 4
COOL MINT LIP BALM 
calendula officinalis flower salve
Product Information
Item Code (Source)NDC: 70994-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/04/2022
Part 4 of 4
UNSCENTED LIP BALM 
calendula officinalis flower salve
Product Information
Item Code (Source)NDC: 70994-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/04/202212/31/2023
Labeler - Spry Life LLC (100791947)

Revised: 1/2024
 

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