Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredient Padimate O, Petrolatum
Dosage and administration Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply liberally 15 minutes before sun exposure. Reapply as needed. Children under 6 months of age: Ask a doctor before use.
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Red 6 Lake (CI 15850), Yellow 5 Lake (CI 19140), Methylparaben
Indications and usage A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.
Purpose Information about the drug product’s indications for use.
Purpose Sunscreen, Skin Protectant
Spl product data elements Usually a list of ingredients in a drug product.
Winco Original SPF 4 Lip Balm Padimate O, Petrolatum PETROLATUM PETROLATUM LIGHT MINERAL OIL MICROCRYSTALLINE WAX LANOLIN PADIMATE O PADIMATE O CERESIN CARNAUBA WAX ISOPROPYL MYRISTATE
Package label principal display panel The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package/Label Principal Display Panel Winco SPF Original Lip Balm Twin Pack
Keep out of reach of children Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children If swallowed get medical help or contact a Poison Control Center right away.
Warnings Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 Do not use on damaged or broken skin Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children: If swallowed get medical help or contact a Poison Control Center right away.