Otc - Active Ingredient
Active ingredient,
Octocrylene – 10 %
Octisalate – 5%
Homosalate – 5%
Avobenzone – 2.5 %
Sea Clearly Hydrating Facial Spf 35 Kinetin Cream
FDA Label NDC 62742-4237
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Sea Clearly Hydrating Facial Spf 35 Kinetin (NDC 62742-4237). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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
Uses. Helps prevent sunburn.
If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eye.Rinse with water to remove.
Otc - Stop Use
Stop use and ask doctor if skin rash occurs.
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 generously and evenly 15 minutes before sun exposure.
Reapply: after 40 minutes of swimming or sweating.
Immediately after towel drying. At least every 2 hours.
Sun Protection Measures: Spending time the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of 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.
Other Safety Information
Other information.
Protect this product from excessive heat and direct sun.
Inactive Ingredient
Inactive ingredient:
Isododecane, Polymethylsilsesquioxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Dimethicone Crosspolymer, Dimethicone,Camellia Oleifera (Seed) Oil,Prunus Armeniaca (Apricot) Kernel Oil, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Kinetin, Squalane,Tocopherol, Tocopheryl Acetate.
* Please review the disclaimer below.
