Active Ingredient
Zinc Oxide (10.0%)
Spf 15 - Zinc Oxide Lip Balm Stick
FDA Label NDC 63645-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oralabs for the product Spf 15 - Zinc Oxide Lip Balm (NDC 63645-182). 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
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 to prevent sunburn, skin cancer and/or early aging.
For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.
Directions
Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes
of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun
Protection Measures. Spending time in the sun increases your risk of skin cancer and
early skin aging • To decrease the risk, regularly use a sunscreen with a broad spectrum
SPF of 15 or higher and other sun protection measures including: limit time in the sun,
especially from 10 a.m. -2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.
Inactive Ingredients
Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Behenyl Behenate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Caprylic/CapricTriglyceride, Flavor, Euphorbia Cerifera (Candelilla) Wax, Persea Gratissima (Avocado) Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea Butter),Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Helianthus Annuus(Sunflower) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Melaleuca
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