Otc - Active Ingredient
Active ingredient(s)
Homosalate 10.0%
Octocrylene 10.0%
Ethylhexyl Salicylate 5.0%
Avobenzone 3.0%
Medifordear Cica Calming Sunscreen Cream
FDA Label NDC 72169-550
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Youngwon Costech Co.,ltd. for the product Medifordear Cica Calming Sunscreen (NDC 72169-550). 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, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Use(s)
- 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
Warning
- 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 irritation or rash occurs.
- Keep out of reach of children if product is 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 if product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply 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 SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m.-2p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.
Other Safety Information
Other Information
-Protect the product in this container from excessive heat and direct sun
Otc - Questions
Questions
www.lookatmecos.com
Inactive Ingredient
Inactive ingredients
Water, Butylene Glycol, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Tocopheryl Acetate, Panthenol, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid
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