PLAGENTRA SOOTHING REVOLUTION SUNCITY

Manufacturer
C.A Pharm Co., Ltd.
Effective date
2014-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:41:01

Label at a glance#

ProductPLAGENTRA SOOTHING REVOLUTION SUNCITY
Active ingredientOCTINOXATE, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 5.0%, ETHYLHEXYL SALICYLATE 5.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Water, Butylene Glycol, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Titanium Dioxide, Polysorbate 60, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Stearic Acid, Hexyl Laurate, Sorbitan Stearate, VP/Eicosene Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Isohexadecane, Caprylyl glycol, Ethylhexylglycerin, Panthenol, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (Olive) Fruit Oil, Polysorbate 80, Xanthan Gum, Glycine Soja (Soybean) Sterois, Magnesium Aluminium Silicate, Tropolone, Leuconostoc/Radish Root Ferment Filtrate, Disodium EDTA, Polyglutamic Acid, Centellia Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, Ethyl Ascorbyl Ether, Human Oligopeptide-1, Oligopeptide-3

PURPOSE

OTC - PURPOSE SECTION

Purpose: UVA/UVB Protection

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

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 on ounce of sunscreen.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.capharm.co.kr/plagentra soothing revolution suncity carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68988-120-012020-01-31C16284748780-19d75b9d0-3aae-f424-e053-dadaa90a57cee0b232cf-b526-4732-a358-6d9e826ec7b4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68988-120-01PLAGENTRA SOOTHING REVOLUTION SUNCITY45 g in 1 CARTONCREAM452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68988-120PLAGENTRA SOOTHING REVOLUTION SUNCITY (OCTINOXATE, OCTISALATE) CREAM [C.A PHARM CO., LTD.]2Legacy NDC, 1 package rows20141205_e0b232cf-b526-4732-a358-6d9e826ec7b4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68988-12068988-120-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f15581ea-514d-44c8-af6d-0472d5d4bf0ce0b232cf-b526-4732-a358-6d9e826ec7b42014-12-05WarningsExact identifier
spl id: f15581ea-514d-44c8-af6d-0472d5d4bf0c
spl set id: e0b232cf-b526-4732-a358-6d9e826ec7b4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.