Carecella
FDA Label NDC 69422-1302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by General Bio Co., Ltd. for the product Carecella (NDC 69422-1302). 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, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3%
Octinoxate 7.5%
Octocrylene 7.5%
Purpose
Sunscreen
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
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.
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.
Directions
• Apply liberally and evenly 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor
• 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 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.
Inactive Ingredients
Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol, Dipropylene Glycol, Trisiloxane, Common Purslane (Portulaca Oleracea) Extract, 1,2-Hexanediol, Magnesium Aluminum Silicate, Arginine, Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, Cetearyl Alcohol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Disodium EDTA, Scots Pine (Pinus sylvestris) Leaf Oil, Adenosine, Sodium Hyaluronate, Hydrolyzed Collagen Extract, Comfrey (Symphytum Officinale) Leaf Extract, Hydrogenated Lecithin, Diethoxyethyl Succinate, Phospholipids, Caprylic/Capric Triglyceride, Ceramide NP, Wild Mint (Mentha Arvensis) Leaf Oil, Polyglyceryl-10 Laurate, Caprylyl Glycol, Copper Tripeptide-1, Tripeptide-29, Nicotinoyl Tripeptide-1, Hexapeptide-9, Acetyl Hexapeptide-8
Other Information
• Protect the product in this container from excessive heat and direct sun.
Questions Or Comments?
Call +1-213-568-3732
Monday-Friday 9 a.m.-6 p.m. Pacific Time
You may also report serious side effects to this phone number
Other
Protects your skin from the external sun light during the day, as well as moisturizes the skin.
SUNSCREEN CREAM
BROAD SPECTRUM SPF 50
Distributed by GCOOP USA CORP. 1032 S. Crenshaw Blvd. #C-2 2ND Floor Los Angeles, CA 90019 Visit at us.gcoop.com
GB GENERAL BIO
Made in Korea
* Please review the disclaimer below.
