JUNGSAEMMOOL Essential Star Cealer Foundation Medium Deep: Package Insert and Label Information

JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM DEEP- titanium dioxide, octinoxate and 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.

Titanium Dioxide 12.63%
Octinoxate 4.00%
Zinc Oxide 0.93%

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, Iron Oxides (CI 77492), Dipropylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, Pentylene Glycol, Polypropylsilsesquioxane, Disteardimonium Hectorite, Trimethylsiloxyphenyl Dimethicone, Magnesium Sulfate, Iron Oxides (CI 77491), Phenoxyethanol, Methyl Methacrylate Crosspolymer, Silica, Beeswax, Lauroyl Lysine, Sorbitan Isostearate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Aluminum Hydroxide, Ceresin, Stearic Acid, Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA

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

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JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM DEEP
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 126.3 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 40 mg in 1 g
ZINC OXIDE (ZINC CATION) ZINC CATION 9.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
PHENYL TRIMETHICONE
TRIETHYLHEXANOIN
CYCLOMETHICONE 5
FERRIC OXIDE YELLOW
DIPROPYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
PEG-10 DIMETHICONE (600 CST)
CYCLOMETHICONE 6
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
PENTYLENE GLYCOL
MAGNESIUM SULFATE, UNSPECIFIED FORM
FERRIC OXIDE RED
PHENOXYETHANOL
SILICON DIOXIDE
YELLOW WAX
LAUROYL LYSINE
SORBITAN ISOSTEARATE
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
FERROSOFERRIC OXIDE
TRIETHOXYCAPRYLYLSILANE
ALUMINUM HYDROXIDE
CERESIN
STEARIC ACID
DIMETHICONE
ETHYLHEXYLGLYCERIN
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
ADENOSINE
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71261-005-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71261-005-01)
1 NDC:71261-005-01 15 g in 1 CONTAINER This package is contained within the CARTON (71261-005-02)
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 Operations
Cosmax, Inc 689049693 manufacture (71261-005)

Revised: 11/2019 Jungsaemmool Beauty Co., Ltd.

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