Otc - Active Ingredient
OCTINOXATE 7.00%
OCTISALATE 4.50%
Uniwell Aqua Suncream
FDA Label NDC 71502-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uniwell Ltd for the product Uniwell Aqua Suncream (NDC 71502-001). 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, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, 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
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months
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 using and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Methyl Methacrylate Crosspolymer, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sorbitan Olivate, Polysorbate 60, PEG-100 Stearate, Sorbitan Stearate, Dimethicone, Polyacrylate-13, Panthenol, Caprylyl Glycol, Sodium Hydroxide, Polyisobutene, Ethylhexylglycerin, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Disodium EDTA, Propolis Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Adenosine, Polysorbate 20, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Sorbitan Isostearate, Panax Ginseng Root Extract, Portulaca Oleracea Extract, Ecklonia cava Extract, Codium Tomentosum Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Glycerin, Geranium Maculatum Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Santalum Album (Sandalwood) Oil, Rose Flower Oil, Chamomilla Recutita (Matricaria) Flower Oil, Olea Europaea (Olive) Leaf Extract, Alcohol, Anthemis Nobilis Flower Extract, Brassica Oleracea Italica (Broccoli) Extract, Phenoxyethanol, Styrax Benzoin Gum, Commiphora Myrrha Oil, Aloe Barbadensis Leaf Juice, Gossypium Herbaceum (Cotton) Extract, Potassium sorbate, Sodium Benzoate
* Please review the disclaimer below.
