JUNGSAEMMOOL MASTERCLASS GLOW BASE- octinoxate, titanium dioxide, homosalate, octisalate cream

JUNGSAEMMOOL Masterclass Glow Base by

Drug Labeling and Warnings

JUNGSAEMMOOL Masterclass Glow Base by is a Otc medication manufactured, distributed, or labeled by Jungsaemmool Beauty Co., Ltd., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.00%
Titanium Dioxide 5.47% 
Homosalate 3.00% 
Octisalate 2.00% 

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

WARNINGS

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 CHILDREN

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

INACTIVE INGREDIENT

WATER, PROPANEDIOL, GLYCERIN, BUTYLENE GLYCOL, DIETHYLHEXYL 2,6-NAPHTHALATE, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, 1,2-HEXANEDIOL, ALCOHOL DENAT., PENTYLENE GLYCOL, POLYHYDROXYSTEARIC ACID, VP/EICOSENE COPOLYMER, POLYSORBATE 60, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, CETYL PEG/PPG-10/1 DIMETHICONE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE, DICAPRYLYL CARBONATE, ALUMINA, SQUALANE, STEARIC ACID, DIMETHICONE, METHYL HYDROGENATED ROSINATE, ALUMINUM HYDROXIDE, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, ETHYLHEXYLGLYCERIN, POLYACRYLATE CROSSPOLYMER-6, NEOPENTYL GLYCOL DIETHYLHEXANOATE, SODIUM STEAROYL GLUTAMATE, IRON OXIDES(CI 77491), ADENOSINE, SODIUM POLYACRYLATE, IRON OXIDES(CI 77492), CITRIC ACID, SORBITAN ISOSTEARATE, POLYETHER-1, T-BUTYL ALCOHOL, HYDROLYZED SODIUM HYALURONATE, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, SACCHARIDE ISOMERATE, AGAVE TEQUILANA LEAF EXTRACT, TOCOPHEROL, HYDROGENATED LECITHIN, POLYGLYCERYL-10 STEARATE, SODIUM HYALURONATE, ROSE EXTRACT, PANTHENOL, SODIUM CITRATE, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, RETINYL PALMITATE, BIOTIN, CYANOCOBALAMIN, SODIUM ACETYLATED HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, THIAMINE HCL, POTASSIUM HYALURONATE, FOLIC ACID, PYRIDOXINE, HYDROLYZED HYALURONIC ACID, HYALURONIC ACID

OTHER SAFETY INFORMATION

Protect the product in the container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL MASTERCLASS GLOW BASE 
octinoxate, titanium dioxide, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	54.7 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
NIACINAMIDE (UNII: 25X51I8RD4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALCOHOL (UNII: 3K9958V90M)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALUMINUM OXIDE (UNII: LMI26O6933)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ADENOSINE (UNII: K72T3FS567)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
BIOTIN (UNII: 6SO6U10H04)
CYANOCOBALAMIN (UNII: P6YC3EG204)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
THIAMINE HYDROCHLORIDE (UNII: M572600E5P)
FOLIC ACID (UNII: 935E97BOY8)
PYRIDOXINE (UNII: KV2JZ1BI6Z)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-025-02	1 in 1 CARTON	08/01/2022
1	NDC: 71261-025-01	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 Drug	M020	08/01/2022

Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)

Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA CO., LTD Gwanjeong 2 branch		695128936	manufacture(71261-025)