JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION BRONZE- titanium dioxide, octinoxate, octisalate cream

JUNGSAEMMOOL Essential Skin Nuder Cushion Bronze by

Drug Labeling and Warnings

JUNGSAEMMOOL Essential Skin Nuder Cushion Bronze by is a Otc medication manufactured, distributed, or labeled by Jungsaemmool Beauty Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 6.51%
Octinoxate 6.70%
Octisalate 4.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

For sunscreen use:
Apply liberally 15 minutes before sun exposure

Reapply at least every two hours
Use a water-resistant sunscreen if swimming or sweating
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, Titanium Dioxide (CI 77891), Glycerin, Propanediol, Trimethylsiloxysilicate, PEG-10 Dimethicone, Iron Oxides (CI 77492), Cetyl Ethylhexanoate, Trisiloxane, 1,2-Hexanediol, Caprylyl Methicone, Dimethicone, Hydrogenated Coconut Oil, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Disteardimonium Hectorite, Magnesium Sulfate, Synthetic Fluorphlogopite, Iron Oxides (CI 77491), Acrylates/Dimethicone Copolymer, Cetyl PEG/PPG-10/1 Dimethicone, Iron Oxides (CI 77499), Stearic Acid, Triethoxycaprylylsilane, Alumina, Aluminum Hydroxide, Glyceryl Caprylate, Fragrance(Parfum), Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, BHT, Mica (CI 77019), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tin Oxide

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION BRONZE 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65.1 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
TRISILOXANE (UNII: 9G1ZW13R0G)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-039-02	2 in 1 CARTON	10/14/2024
1	NDC: 71261-039-01	14 g 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 Drug	M020	10/14/2024

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(71261-039)