FDA Label for Spf 45 - Lip Balm
View Indications, Usage & Precautions
Spf 45 - 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
Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant
Purpose
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. Helps prevent wind burned and chapped lips.
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
C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Mineral Oil, Ozokerite, Phenyl Trimethicone, Tocopherol
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