Active Ingredients
Avobenzone 2.84%
Homosalate 7.0 %
Octisalate 4.5%
Octocrylene 9.0%
Centella Relief Soothing Sunscreen Lotion
FDA Label NDC 83403-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Iunik Co., Ltd. for the product Centella Relief Soothing Sunscreen (NDC 83403-100). 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 active ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, centella relief soothing sunscreen, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.
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 use and ask a doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children
- If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- 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 10 a.m.–2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months of age: Ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
Inactive Ingredients
Water, Tripropylene Glycol, Propanediol, Silica, Ethylhexyl Methoxycrylene, Diethylhexy 2,6-Naphthalate, 1,2-Hexanediol, Enantia Chlorantha Bark Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Saccharomyces Ferment, Dimethicone, Methyl Trimethicone, Pentylene Glycol, Hydroxyethyl Urea, Poly C10-30 Alky Acrylate, Cetearyl Olivate, Polyacrylic Acid, Tromethamine, Sorbitan Olivate, Dipotassium Phosphate, Acetyl Glutamine, Sodium Stearoyl Glutamate, Butylene Glycol, Ethylhexylglycerin, Cellulose Gum, Tocopherol, Oleanolic Acid, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Cetyl Alcohol, Carborer, Xanthan Gum
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