Otc - Active Ingredient
Titanium Dioxide 5.75%
Zinc Oxide 14.5%
Karyng Complete Spf Sunscreen Cream
FDA Label NDC 85321-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Karyng Llc for the product Karyng Complete Spf Sunscreen (NDC 85321-001). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, user safety warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Warnings
For external use only.
Otc - When Using
Do not get into eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash or irritation 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
Directions:
Apply liberally 15 minutes before sun exposure.
Reapply after at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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 value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10am-2pm
Wear long-sleeved shirts, pants, hats and sunglasses
Children under six months of age, ask a doctor
User Safety Warnings
Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Other Safety Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Steareth-2, Pentylene Glycol, Silica, Steareth-21, Polyhydroxystearic Acid, Cetearyl Alcohol. Echinacea Purpurea Extract. Swertia Chirata Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Litsea Cubeba Oil, Copper Lysinate/Prolinate, Dipotassium Glycyrrhizate, Sodium Stearoyl Glutamate, Stearic Acid, Propanediol Cetearyl Glucoside, Methylglucoside Phosphate, Lecithin, Triethoxycaprylylsilane, Isopropyl Palmitate, Sodium C14-16 Olefin Sulfonate, Trisodium Ethylenediamine Disuccinate. Alumina, Xanthan Gum, Caprylhydroxamic Acid, Caprylyl Glycol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).
Indications & Usage
Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.
Package Label.Principal Display Panel
Cslm01 (Cslm01)
Cslm02 (Cslm02)
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