JUNGSAEMMOOL SKIN SETTING TONE BALANCING BASE- titanium dioxide, octinoxate, zinc oxide, octisalate cream 
Jungsaemmool Beauty Co., Ltd.

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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71261-010_JUNGSAEMMOOL Skin Setting Tone Balancing Base

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

Sunscreen

Helps prevent sunburn

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

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, 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

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

image description

JUNGSAEMMOOL SKIN SETTING TONE BALANCING BASE 
titanium dioxide, octinoxate, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE91 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION49 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-010-021 in 1 CARTON07/14/2020
1NDC:71261-010-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/14/2020
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Shinsegae Intercos Korea Inc.694526100manufacture(71261-010)

Revised: 7/2020
Document Id: aa6f090a-a7ea-1163-e053-2a95a90a4b92
Set id: 7070e628-d9de-4702-b3d5-739356f3e512
Version: 1
Effective Time: 20200714
 
Jungsaemmool Beauty Co., Ltd.