Otc - Active Ingredient
Active Ingredient
Zinc Oxide 9.0%
Titanium Dioxide 7.0%
Alba Botanica Baby Mineral Sunscreen Spf45
FDA Label NDC 61995-2017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Hain Celestial Group, Inc. for the product Alba Botanica Baby Mineral Sunscreen Spf45 (NDC 61995-2017). 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, dosage & administration, otc - purpose, warnings, otc - keep out of reach of children, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.Children under 6 months: ask a doctor.
Otc - Purpose
Sunscreen
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 Poison Center right away.
Inactive Ingredient
Water, Caprylic Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes,Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Aloe Barbadensis Leaf Juice(1), Crambe Abyssinica Seed Oil, Polyhydroxystearic Acid, Alumina, Stearic Acid, Butyrospermum Parkii (Shea) Butter, Camilla Sinensis Leaf Extract (1), Echinacea Purpurea Extract, Ginkgo Biloba Leaf Extract (1), Polygonum Aviculare Extract, Tocopheryl Acetate, Citric Acid, Coco-Caprylate/Caprate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.
(1) Certified Organicf Ingredient
Indications & Usage
Helps prevents sunburns. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.
Package Label.Principal Display Panel
Al01017 Label (Al01017)
* Please review the disclaimer below.
