Otc - Active Ingredient
Active Ingredient
Avobenzone -3.0%
Octocrylene -10.0%
Octyl Salicylate - 5.0%
Al0043800 Alba Botanica Sheer Shield Sunscreen Ff Spf50
FDA Label NDC 61995-3438
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 Al0043800 Alba Botanica Sheer Shield Sunscreen Ff Spf50 (NDC 61995-3438). 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 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(1), Coco-Caprylate/Caprate, Water, Stearyl/Octyldodecyl/Citrate Crosspolymer, Glycerin, Glyceryl Stearate SE, Shea Butter Ethyl Esters, C14-22 Alcohols, Mica, Polyglyceryl-10 Pentastearate, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Argania Spinosa Kernel Oil (1), Bambusa Vulgaris Stem Extract, Simmondsia Chinensis (Jojoba) Seed Oil (1), Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Fruit Juice, Rosa Centifolia Flower Extract, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Behenyl Alcohol, C12-20 Alkyl Glucoside, Biosaccharide Gum-1, Citric Acid, Glyceryl Caprylate, Potassium Hydroxide, Quartz, Sodium Anisate,Sodium Levulinate, Ethylhexylglycerin,
(1) Certified Organicf Ingredient
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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