Active Ingredient
Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%)
Petrolatum (38.8%)
Designer Lip Smoothie Spf 15 Lip Balm Stick
FDA Label NDC 84061-127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Australian Gold for the product Designer Lip Smoothie Spf 15 Lip Balm (NDC 84061-127). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen, Sunscreen, Skin Protectant
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Uses
Helps prevent sunburn. Helps prevent and temporarily protect dry, chapped, or windburned lips.
Warnings
For external use only: When using this product. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash or irritation develops and lasts.
Directions
Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months: Ask a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut ) Oil, Ethylhexyl Methoxycrylene, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Microcrystalline Wax, Olea Europaea (Olive) Fruit Oil, Ozokerite, Saccharin, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.
* Please review the disclaimer below.
