Otc - Active Ingredient
Homosalate 15.0%
Ethylhexyl Methoxycinnamate 7.5%
Octocrylene 8.0%
Ethylhexyl Salicylate 5.0%
Butyl Methoxybenzoylmethane 3.0%
The following Structured Product Label (SPL) was submitted to the FDA by The Hain Celestial Group, Inc. for the product Al0038100 Alba Hw Sunscreen Coconut Milk Spf50 (NDC 61995-2843). 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.
Homosalate 15.0%
Ethylhexyl Methoxycinnamate 7.5%
Octocrylene 8.0%
Ethylhexyl Salicylate 5.0%
Butyl Methoxybenzoylmethane 3.0%
Sunscreen
For external use only. Flammable.Do not use near heat, sparks or flames or while smoking. Do not puncture or incinerate. Contents under preassure. Do not store at temperature above 120°C. Do not use on damaged or broken skin. When using this product keep out of eye. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Apply liberally 15 minutes before sun exposure.Hold 4 to 6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Use in well- ventilated areas. Reapply after 80 min of swimming or sweating, immediately after towel drying and at lease every two hrs. Children under 6 months: 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.
Alcohol, Acrylates/Octylacrylamide Copolymer, Persea Gratissima (Avocado) Oil, Diisopropyl Adipate, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Chamomilla Recuitita (Matricaria) Flower Extract, Cocos Nucifera (Coconut) Fruit Extract, Panax Ginseng Root Extract, Gingko Biloba Root Extract, Prunus Armeniaca (Apricot) Fruit Extract, Buturospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Glycerin, Tocopheryl Acetate, Vanillin, Potassium Sorbate, Sodium Benzoate, Coumarin, Anisyl Alcohol.
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