Active Ingredient
Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.0%
Plagentra Baby Suncity
FDA Label NDC 68988-090
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.a Pharm Co., Ltd. for the product Plagentra Baby Suncity (NDC 68988-090). 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 ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Water, Cyclopentasiloxane, Isohexadecane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Glycerin, Polysorbate 60, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, Dimethicone Crosspolymer, Sorbitan Stearate, Stearic Acid, VP/Eicosene Copolymer, PEG-100 Stearate, Cetearyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, PEG-10 Dimethicone, Hexyl Laurate, Panthenol, Caprylyl glycol, Fragrance, Ethylhexylglycerin, Tropolone, Tocopheryl Acetate, Alumina, Magnesium Aluminum Silicate, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Arnica Montana Flower Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Xanthan Gum, Disodium EDTA, Sodium Hyaluronate, Ethyl Ascorbyl Ether, Human Oligopeptide-1, Oligopeptide-3
Purpose
Purpose: UVA/UVB Protection
Warnings
Warnings:
1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :
1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.
2. Do not apply the product to wounds or skin with dermatitis such as eczema.
3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.
4. It contains AHA. If it is your first time to use this product, take a small amount and gently apply to the skin to check if it cause andy trouble to your skin.
Keep Out Of Reach Of Children
Keep out of reach of babies and children.
Indications & Usage
Indication and usage:
1) Tighten the lid after using it.
2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
3) Use it on the day you will be in the sun, 30 minutes before you go outside, apply an ounce of sunscreen.
Dosage & Administration
Dosage and administration:
To apply sunscreen, squeeze a dollop of sun cream onto your hand and rub it all the skin that will be exposed to UV.
* Please review the disclaimer below.
