Otc - Active Ingredient
Active Ingredients
Octocrylene 10%, Octisalate 5%, Avobenzone 2.5%
Beyond Balm Lip Sunscreen Bs Spf 35 Ointment
FDA Label NDC 62742-4283
12 label sections · Submitted to the FDA by Allure Labs · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Beyond Balm Lip Sunscreen Bs Spf 35 (NDC 62742-4283). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose : SUNSCREENS
Indications & Usage
Uses
• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings
• For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask doctor if skin rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions • Apply generously and evenly 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.
Other Safety Information
Other information - Protect this product from excessive heat and direct sun. May stain fabrics
Inactive Ingredient
Inactive Ingredients - Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Rhus Verniciflua Peel Wax, Euphorbia Cerifera (Candelilla) Wax, Butyloctyl Salicylate, Simmondsia Chinensis (Jojoba) Seed Oil, Flavor (Aroma), Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii Nut Extract, Tocopherol, Kinetin, Beta-Sitosterol, Squalene, Rubus ldaeus (Red Raspberry) Seed Oil, Hyaluronic Acid, Argania Spinosa Kernel Oil, Olea Europaea (Olive) Fruit Oil, Benzyl Benzoate, Vanillin
Package Label.Principal Display Panel
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