JUNGSAEMMOOL ESSENTIAL SKIN NUDER LONGWEAR CUSHION MEDIUM DEEP- titanium dioxide, octinoxate, zinc oxide, octisalate cream

JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium Deep by

Drug Labeling and Warnings

JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium Deep 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 2.90%
Octinoxate 7.00%

Zinc Oxide 4.90%
Octisalate 4.50%

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), Methyl Methacrylate Crosspolymer, Butylene Glycol, Methyl Trimethicone, Dimethicone, Glycerin, Niacinamide, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Iron Oxides (CI 77492), Caprylyl Methicone, Butylene Glycol Dicaprylate/Dicaprate, PEG/PPG-17/6 Copolymer, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Magnesium Sulfate, Phenoxyethanol, Aluminum Hydroxide, Sorbitan Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Iron Oxides (CI 77491), Stearic Acid, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Adenosine, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Ceramide NP, Helianthus Annuus (Sunflower) Seed Oil, Panthenol, BHT, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopherol, Freesia Refracta Extract, Iris Ensata Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Lilium Candidum Bulb Extract, Narcissus Pseudonarcissus (Daffodil) Flower Extract, Rose Extract

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 LONGWEAR CUSHION MEDIUM DEEP 
titanium dioxide, octinoxate, zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	29 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
SAFFLOWER OIL (UNII: 65UEH262IS)
CERAMIDE NP (UNII: 4370DF050B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
NARCISSUS PSEUDONARCISSUS FLOWER (UNII: L879RBF1WN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-038-02	2 in 1 CARTON	08/04/2024
1	NDC: 71261-038-01	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	08/04/2024

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(71261-038)