Otc - Active Ingredient
Avobenzone 3%
Homosalate 10%
Octocrylene 10%
Octisalate 5%
Hawaiian Spf 30 Aloe Sunscreen
FDA Label NDC 61995-2028
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 Hawaiian Spf 30 Aloe Sunscreen (NDC 61995-2028). 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
● 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
● wear long-sleeved shirts, pants, hats, and sunglasses
Otc - Purpose
Sunscreen
Warnings
For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Inactive Ingredient
Water (Aqua), Butyloctyl Salicylate, Dodecane, VP/Hexadecene Copolymer, Polyglyceryl-10 Pentastearate, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Glyceryl Oleate Citrate, Behenyl Alcohol, Phenoxyethanol, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/ Stem Extract (1), Panax Ginseng Root Extract (1), Tocopheryl Acetate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Decane, Nonane, Potassium Hydroxide, Sodium Phytate, Sodium Stearoyl Lactylate, Solanum Tuberosum (Potato) Starch, Sorbitan Olivate, Alcohol (1), Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate
(1) Certified Organic Ingredient
Indications & Usage
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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