JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION LIGHT- titanium dioxide, octinoxate, 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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71261-001_JUNGSAEMMOOL Essential Skin Nuder Cushion Light

Titanium Dioxide 13.19%
Octinoxate 6.70%
Octisalate 4.00%

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, Trimethylsiloxysilicate, Glycerin, PEG-10 Dimethicone, Butylene Glycol, Niacinamide, Cetyl Ethylhexanoate, Pentylene Glycol, Iron Oxides (CI 77492), VP/Hexadecene Copolymer, Caprylyl Methicone, Polypropylsilsesquioxane, Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Synthetic Fluorphlogopite, Stearic Acid, Disteardimonium Hectorite, Iron Oxides (CI 77491), Alumina, Acrylates/Dimethicone Copolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Dimethicone, Fragrance(Parfum), Iron Oxides (CI 77499), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica (CI 77019), Tin Oxide (CI 77861), Polyglutamic Acid

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

image description

JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION LIGHT 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE131.9 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
ADENOSINE (UNII: K72T3FS567)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
MICA (UNII: V8A1AW0880)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-001-021 in 1 CARTON10/16/2020
1NDC:71261-001-0114 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:71261-001-042 in 1 CARTON10/16/2020
2NDC:71261-001-0314 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/16/2020
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(71261-001)

Revised: 7/2021
Document Id: c61886a3-f5c3-3d95-e053-2995a90ab1d3
Set id: cc90067d-d4b0-47f4-b603-718f85e0cda9
Version: 6
Effective Time: 20210701
 
Jungsaemmool Beauty Co., Ltd.