JUNGSAEMMOOL SKIN NUDER COVER LAYER CUSHION MEDIUM- titanium dioxide, octinoxate, octisalate cream

JUNGSAEMMOOL Skin Nuder Cover Layer Cushion Medium by

Drug Labeling and Warnings

JUNGSAEMMOOL Skin Nuder Cover Layer Cushion Medium 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 19.34%
Octinoxate 6.70%
Octisalate 4.00%

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, Cyclopentasiloxane, Iron Oxides (CI 77492), Propanediol, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl, Dimethicone, Trimethylsiloxysilicate, Cetyl Ethylhexanoate, Niacinamide, Isododecane, 1,2-Hexanediol, Methyl Trimethicone, Acrylates/Dimethicone Copolymer, PEG-10 Dimethicone, Disteardimonium Hectorite, Silica, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Magnesium Sulfate, Mica (CI 77019), Iron Oxides (CI 77491), Triethoxycaprylylsilane, Aluminum Hydroxide, Iron Oxides (CI 77499), Cetearyl Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecanol, Stearic Acid, Alumina, Polyhydroxystearic Acid, Fragrance(Parfum), Polypropylsilsesquioxane, Polyglyceryl-4 Isostearate, Adenosine, Trisodium Ethylenediamine Disuccinate, Neopentyl Glycol Diethylhexanoate, Dimethicone, Isopropyl Titanium Triisostearate, Tocopherol, Glycerin, Hydrolyzed Sodium Hyaluronate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Ceramide NP, Sodium Stearoyl Glutamate

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL SKIN NUDER COVER LAYER CUSHION MEDIUM 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	193.4 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)
PROPANEDIOL (UNII: 5965N8W85T)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NIACINAMIDE (UNII: 25X51I8RD4)
ISODODECANE (UNII: A8289P68Y2)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ADENOSINE (UNII: K72T3FS567)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-024-02	2 in 1 CARTON	03/28/2022
1	NDC: 71261-024-01	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 final	part352	03/28/2022

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(71261-024)