Active Ingredient
Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)
Australian Gold Spf 15 Lip Balm Stick
FDA Label NDC 84061-128
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 Australian Gold Spf 15 Lip Balm (NDC 84061-128). 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, Sunscreen, Sunscreen, Skin Protectant
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Uses
Prevents Sunburns
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.
For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.
Directions
Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.
Inactive Ingredients
Synthetic Beeswax, Cetyl Alcohol, Mineral Oil, Paraffin, Polyethylene, Flavor, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Aluminum Hydroxide, Lanolin, Phenyl Trimethicone, Oleyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, BHT, Tocopheryl Acetate, Propyl paraben, Aloe Barbadensis Leaf Extract, Methylparaben, Sodium Saccharin.
* Please review the disclaimer below.
