81100_001_HYALURONIC ACID WATERY SUN GEL

HYALURONIC ACID WATERY SUN gel by

Drug Labeling and Warnings

HYALURONIC ACID WATERY SUN gel by is a Otc medication manufactured, distributed, or labeled by isntree, Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYALURONIC ACID WATERY SUN GEL- octisalate, homosalate gel 
isntree

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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81100_001_HYALURONIC ACID WATERY SUN GEL

Homosalate 4%
Octisalate 4%

 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.

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.

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

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.

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

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

HYALURONIC ACID WATERY SUN GEL 
octisalate, homosalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81100-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
BEMOTRIZINOL (UNII: PWZ1720CBH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BISOCTRIZOLE (UNII: 8NT850T0YS)
POLYSILICONE-15 (UNII: F8DRP5BB29)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETETH-10 (UNII: LF9X1PN3XJ)
TROMETHAMINE (UNII: 023C2WHX2V)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
PURSLANE (UNII: M6S840WXG5)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
GLYCERIN (UNII: PDC6A3C0OX)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FIG (UNII: TGD87RII2U)
ASTAXANTHIN (UNII: 8XPW32PR7I)
MARITIME PINE (UNII: 50JZ5Z98QY)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONIC ACID (UNII: S270N0TRQY)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIBUTYL ADIPATE (UNII: F4K100DXP3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81100-001-02	1 in 1 CARTON	12/26/2020	02/22/2023
1	NDC: 81100-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/26/2020	02/22/2023

Labeler - isntree (689043012)

Registrant - isntree (689043012)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(81100-001)

Revised: 2/2023

Document Id: f54fee05-304c-334c-e053-2995a90a577b

34390-5

Set id: 796eda7d-edf8-4fbb-9ba2-76b8590237e8

Version: 3

Effective Time: 20230222