Drug Facts
Active Ingredient....................Purpose
Homosalate 8.00%..................Sunscreen
Octilsalate 5.00%..................Sunscreen
Octocrylene 5.50%..................Sunscreen
Avobenxone 3.00%..................Sunscreen
Asystem Daily Defense Moisturizer Spf30
FDA Label NDC 52261-4900
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Asystem Daily Defense Moisturizer Spf30 (NDC 52261-4900). 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 drug facts, uses, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
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.
Warnings
For external use only.
Otc - Do Not Use
Do not use on broken or damaged skin.
Otc - When Using
When using the product keep out of eyes.
Rinse with water to remove.
Otc - Ask Doctor
Seek out a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, call a doctor or poison control center immediately.
Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours, as well as after 40 minutes of sweating, immediately after towel drying.
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 least a broad spectrum SPF of 15 or higher and other sun protecting measures including: limiting time in the sun, especially from 10am-2pm, and wearing long-sleeved shirts, pants, hats and sunglasses.
For children under 8 months, ask a doctor.
Inactive Ingredients
Aqua (Water), C12-15 Alkyl Benzoate, Glycerin, Diisostearyl Malate, Glyceryl Stearate Citrate, Stearic Acid, Glycol Distearate, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Prunus Amygdalus Dulcia (Sweet Almond) Oil, Actinidia Chinensis (Kiwi) Fruit Extract, Cyanidium Caldarium Extract, Saponaria Pumila Callus Culture Extract, Isomalt, Lecithin, Maltodextrin, Swertia Chirata Leaf Extract, Vitis Vinifera (Grape) Juice Extract, Glycerin, Citrus Vulgaris (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Sodium PCA, Sodium Lactate, Tocopheryl Acetate, Hydoxyethylcellulose, Eucalyptus Globulus Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil
Other Information
Protect this product from excessive heat and direct sun.
Questions?
Inner Package
Inner Package (Daily Defense Moisturizer 30ml)
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