FDA.reportPublic FDA data

HYALURONIC ACID WATERY SUN gel

Manufacturer
isntree | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2020-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:59:53

Label at a glance#

ProductHYALURONIC ACID WATERY SUN gel
Active ingredientHOMOSALATE, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 4%
Octisalate 4%

OTC - PURPOSE SECTION

 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.

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses.

Ask a doctor to use for children under 6 months.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

WARNINGS SECTION

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 using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

WATER, CENTELLA ASIATICA LEAF WATER, ISONONYL WATER, BUTYLENE GLYCOL, DIBUTYL ADIPATE, NIACINAMIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CYCLOPENTASILOXANE, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CETETH-10, TROMETHAMINE, DECYL GLUCOSIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, CETYL PEG/PPG-10/1 DIMETHICONE, SODIUM HYALURONATE, PROPANEDIOL, ETHYLHEXYLGLYCERIN, ADENOSINE, PROPYLENE GLYCOL, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, GLYCERIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, TOCOPHEROL, HYDROGENATED LECITHIN, FICUS CARICA (FIG) FRUIT EXTRACT, CERAMIDE NP, ASTAXANTHIN, PINUS PINASTER BARK EXTRACT, SODIUM ACETYLATED HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, ASCORBYL PROPYL HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, HYDROLYZED SODIUM HYALURONATE, HYDROLYZED HYALURONIC ACID, HYALURONIC ACID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81100-001-022023-02-22C16284748780-1d6a99b39-4d0e-a426-e053-dadaa90af4c281100_001_HYALURONIC ACID WATERY SUN GEL
81100-001-022022-01-28C16284748780-1d6a99b39-4d0e-a426-e053-dadaa90af4c281100_001_HYALURONIC ACID WATERY SUN GEL

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81100-00181100-001-01, 81100-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4IACT
BEMOTRIZINOLPWZ1720CBHIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BISOCTRIZOLE8NT850T0YSIACT
POLYSILICONE-15F8DRP5BB29IACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PENTYLENE GLYCOL50C1307PZGIACT
CETETH-10LF9X1PN3XJIACT
TROMETHAMINE023C2WHX2VIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ADENOSINEK72T3FS567IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XANTHAN GUMTTV12P4NEEIACT
CENTELLA ASIATICA WHOLE7M867G6T1UIACT
PURSLANEM6S840WXG5IACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
GLYCERINPDC6A3C0OXIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
FIGTGD87RII2UIACT
ASTAXANTHIN8XPW32PR7IIACT
MARITIME PINE50JZ5Z98QYIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
HYALURONIC ACIDS270N0TRQYIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIBUTYL ADIPATEF4K100DXP3IACT

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
f54fee05-304c-334c-e053-2995a90a577b796eda7d-edf8-4fbb-9ba2-76b8590237e82023-02-22WarningsExact identifier
spl set id: 796eda7d-edf8-4fbb-9ba2-76b8590237e8

Reported adverse events (FAERS/openFDA)#

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