FDA Label for Spf 15 - Zinc Oxide Lip Balm

View Indications, Usage & Precautions

Spf 15 - Zinc Oxide Lip Balm Product Label

The following document was submitted to the FDA by the labeler of this product Oralabs. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Zinc Oxide (10.0%)


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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