Otc - Active Ingredient
Avobenzone -3%
Homosalate -12.0%
Octocrylene - 7.0%
Octyl Salicylate - 5.0%
Al0038502 Alba Tropical Fruit Kids Sunscreen Spf40
FDA Label NDC 61995-2085
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 Al0038502 Alba Tropical Fruit Kids Sunscreen Spf40 (NDC 61995-2085). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
- Helps prevent sunburn. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun.
Warnings
For external use only. Do not use on damaged or broken skin. 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 a Poison Control Center right away
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 min of swimming or sweating,after towel drying and at lease every two hrs. Children under 6 mos: ask a doctor.
Skin protection measures:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease a risk,regularly use a Sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially 10am- 2pm, wear long- sleeved shirts,pants, hats and sunglasses.
Inactive Ingredient
Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice (1), VP/Hexadecene Copolymer, Sodium Stearoyl Glutamate, Dimethicone, Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract (1), Gingko Biloba Root Extract,Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil,Cetyl Alcohol, Citric Acid, Glyceryl Stearate SE, Potassium Cetyl Phosphate, Sodium Chloride, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, A-Terpinyl Acetate, Dimethylhydroxy Furanone, Nonanal, Vanillin, Limonene.
(1) Certified Organic Ingredient
Otc - Questions
888-659-7730, www.AlbaBotanica.com
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