Purpose Section
Skin Protectant
Kiss-on Lip Balm
FDA Label NDC 70994-404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sierra Sage Herbs Llc for the product Kiss-on Lip Balm (NDC 70994-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose section, active ingredients, indications & usage, keep out of reach of children section, warnings section, storage, dosage & administration section, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Organic Calendula Officinalis (Calendula) Flowers 1X (HPUS)
Indications & Usage
• 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.
• 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
Store at room temperature.
Dosage & Administration Section
Apply as often as needed to affected area.
Inactive Ingredients
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
Kiss-on Lip Balm (Lip Balm Kiss Gg)
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