Otc - Active Ingredient
Zinc Oxide 18.3% (w/w)
Alba Botanica Sensitive Mineral Sunscreen Spf 33
FDA Label NDC 61995-3033
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 Sensitive Mineral Sunscreen Spf 33 (NDC 61995-3033). 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 ● at least every 2 hours. Children under 6 months of age: 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 skin 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
Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Ethyl Macadamiate, Ginkgo Biloba Leaf Extract, Glycerin, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Methyl Dihydroabietate, Microcrystalline Cellulose, Propanediol, Shea Butter Ethyl Esters, Sodium Gluconate, Tocopherol, Water (Aqua)
Indications & Usage
Helps prevents sunburns. If used 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.
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