FDA.reportPublic FDA data

FASCY LAB GREEN PLUS SUN

Manufacturer
FASCY Co,.LTD. | Greencos Co., Ltd.
Effective date
2020-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:35:37

Label at a glance#

ProductFASCY LAB GREEN PLUS SUN
Active ingredientDIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, BEMOTRIZINOL
Label structure8 sections

Indications and uses

Uses Helps prevent sunburn.

Dosage and administration

Directions Apply thoroughly on parts of your skin exposed to the sun. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 2.0%
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 1.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, METHYL METHACRYLATE CROSSPOLYMER, 1,2-HEXANEDIOL, NIACINAMIDE, BEHENYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYISOBUTENE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SILICA, ADENOSINE, CAPRYLYL/CAPRYL GLUCOSIDE, DISODIUM EDTA, SORBITAN OLEATE, SODIUM HYALURONATE

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings: 

1) In case of any abnormal symptoms or side effects such as redness, swelling or itching during and after use, consult a specialist.
2) Avoid using in injured areas.
3) Storage and handling cautions: a) keep away from children, b) keep away from direct sunlight.
4) For external use only

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep away from children

Uses

INDICATIONS & USAGE SECTION

Uses
Helps prevent sunburn.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
Apply thoroughly on parts of your skin exposed to the sun.
Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809685990277GTIN-13: 8809685990277
EAN-13: 8809685990277
GTIN storage (14 digits): 08809685990277		sun carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70991-20070991-200-01, 70991-200-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20ACTIB
BEMOTRIZINOLPWZ1720CBHACTIB
Water059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
NIACINAMIDE25X51I8RD4IACT
DOCOSANOL9G1OE216XYIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ADENOSINEK72T3FS567IACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

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
d723767d-0198-4e10-9710-836981e326c8251fb776-9823-4983-9e27-e7d4502368252021-05-18WarningsExact identifier
spl set id: 251fb776-9823-4983-9e27-e7d450236825

Reported adverse events (FAERS/openFDA)#

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