JUNGSAEMMOOL SKIN SETTING TONE BALANCING BASE- titanium dioxide, octinoxate, zinc oxide, octisalate cream

JUNGSAEMMOOL Skin Setting Tone Balancing Base by

Drug Labeling and Warnings

JUNGSAEMMOOL Skin Setting Tone Balancing Base by is a Otc medication manufactured, distributed, or labeled by Jungsaemmool Beauty Co., Ltd., Shinsegae Intercos Korea Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 9.1%
Octinoxate 7.0%
Zinc Oxide 4.9%
Octisalate 4.5%

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, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Pentaerythrityl Tetraethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica (CI 77019), Butylene Glycol, Glycerin, Niacinamide, Pentylene Glycol, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Tribehenin, Magnesium Sulfate, Iron Oxides (CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Phenoxyethanol, Diphenyl Dimethicone, Stearic Acid, Iron Oxides (CI 77491), Ceresin, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Adenosine, Disodium EDTA, Ethylhexyl Palmitate, Tocopherol, Sodium PCA, Magnesium PCA, Zinc PCA, Silica Dimethyl Silylate, Caprylyl Glycol, Manganese PCA, Actinidia Polygama Fruit Extract, Potassium Sorbate, Sodium Hyaluronate, Hexylene Glycol

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL SKIN SETTING TONE BALANCING BASE 
titanium dioxide, octinoxate, zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	91 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CERESIN (UNII: Q1LS2UJO3A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
MAGNESIUM PIDOLATE (UNII: V5PC588N7G)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MANGANESE PIDOLATE (UNII: 3S6I84YKIV)
ACTINIDIA POLYGAMA FRUIT (UNII: CJA97047JF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-010-02	1 in 1 CARTON	07/14/2020
1	NDC: 71261-010-01	40 mL in 1 CONTAINER; 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	07/14/2020

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Shinsegae Intercos Korea Inc.		694526100	manufacture(71261-010)