Otc - Active Ingredient
Zinc Oxide - 19.6%
Oars And Alps Spf 50 Mineral Lotion
FDA Label NDC 83046-371
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oars And Alps Llc for the product Oars And Alps Spf 50 Mineral (NDC 83046-371). 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, uses, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
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
•
For external use only.
•
Do not use on damaged or broken skin.
•
When using this product keep out of eyes. Rinse with water to remove.
•
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Reapply:
-At least every two hours
-After 80 minutes of swimming or sweating.
-Immediately after towel drying.
Children under six months: Ask a doctor.
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.
Inactive Ingredient
Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sclerocarya Birrea Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water
Other Safety Information
Protect the product in this container from excessive heat and direct sun
Otc - Questions
Contact [email protected]
* Please review the disclaimer below.
