JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION FAIR LIGHT- titanium dioxide, octinoxate, zinc oxide cream 
Jungsaemmool Beauty Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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71261-007_JUNGSAEMMOOL Essential Star cealer Foundation Fair Light

Titanium Dioxide 12.80%
Octinoxate 4.00%
Zinc Oxide 0.98%

Sunscreen

Helps prevent sunburn

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

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 the children. If product is swallowed, get medical help or contact a poison control center right away.

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

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

image description

JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION FAIR LIGHT 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE128 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  
MICA (UNII: V8A1AW0880)  
TOCOPHEROL (UNII: R0ZB2556P8)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-007-021 in 1 CARTON10/20/201712/27/2022
1NDC:71261-007-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/20/201712/27/2022
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(71261-007)

Revised: 12/2022
 
Jungsaemmool Beauty Co., Ltd.