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

JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium by

Drug Labeling and Warnings

JUNGSAEMMOOL Essential Skin Nuder Longwear 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 9.6%
Octinoxate 7.0%
Zinc Oxide 4.9%
Octisalate 4.5%

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, 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, Sorbitan Isostearate, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Stearic Acid, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Fragrance(Parfum), Ethylhexylglycerin, Adenosine, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Ceramide NP, Helianthus Annuus (Sunflower) Seed Oil, Panthenol, 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 
titanium dioxide, octinoxate, zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	96 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)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
SAFFLOWER OIL (UNII: 65UEH262IS)
CERAMIDE NP (UNII: 4370DF050B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PANTHENOL (UNII: WV9CM0O67Z)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
NARCISSUS PSEUDONARCISSUS FLOWER (UNII: L879RBF1WN)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-013-02	2 in 1 CARTON	07/20/2020
1	NDC: 71261-013-01	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 not final	part352	07/20/2020

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(71261-013)