JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM- titanium dioxide, octinoxate, zinc oxide cream

JUNGSAEMMOOL Essential Star cealer Foundation Medium by

Drug Labeling and Warnings

JUNGSAEMMOOL Essential Star cealer Foundation 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 12.80%
Octinoxate 4.00%
Zinc Oxide 0.98%

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, Phenyl Trimethicone, Triethylhexanoin, Cyclopentasiloxane, Dipropylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Pentylene Glycol, Iron Oxides (CI 77492), Methyl Methacrylate Crosspolymer, Polypropylsilsesquioxane, Disteardimonium Hectorite, Trimethylsiloxyphenyl Dimethicone, Magnesium Sulfate, Phenoxyethanol, Silica, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Beeswax, Sorbitan Isostearate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Aluminum Hydroxide, Ceresin, Stearic Acid, Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Silica Dimethyl Silylate, Nelumbo Nucifera Flower Water, Mica (CI 77019), Tocopherol, Tin Oxide (CI 77861)

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	128 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAUROYL LYSINE (UNII: 113171Q70B)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
YELLOW WAX (UNII: 2ZA36H0S2V)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CERESIN (UNII: Q1LS2UJO3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-006-02	1 in 1 CARTON	12/06/2017
1	NDC: 71261-006-01	15 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	12/06/2017

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(71261-006)