Otc - Active Ingredient
AVOBENZONE 2.9%
HOMOSALATE 14.7%
OCTISALATE 4.9%
OCTOCRYLENE 9.5%
Alba Botanica Maximum Sunscreen Spf 70 Spray
FDA Label NDC 61995-3035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hain Celestial Group, Inc for the product Alba Botanica Maximum Sunscreen Spf 70 (NDC 61995-3035). 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, inactive ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, 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
Inactive Ingredient
Alcohol Denat., Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Diisopropyl Adipate, Ethylhexyl Methoxycrylene, Ginkgo Biloba Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Panax Quinquefolius Root Extract, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate
Otc - Purpose
Sunscreen. Helps prevent sunburn
Indications & Usage
● Hold container 4 to 6 inches/ from skin to apply ● Spray liberally/generously and spread evenly by hand 15 minutes before sun exposure. Do not spray directly onto face; spray on hands, then apply to face. Do not apply in windy conditions. Use in a well-ventilated area and avoid inhaling or exposing others to spray. ● reapply: ● at least every 2 hours ● after 40 minutes of swimming or sweating
● immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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 am - 2 pm/ 11 a.m. – 3 p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses. ● For use on children under 6 months of age, ask a doctor.
Warnings
For external use only.
Do not use on damaged or broken skin.
When using this product avoid contact with eyes.If contact occurs, rinse thoroughly with water.
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
* Please review the disclaimer below.
