OTC Medication Information: JUNGSAEMMOOL Essential Skin Nuder Cushion Medium

JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM- titanium dioxide, octinoxate and octisalate 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 13.19%
Octinoxate 6.70%
Octisalate 4.00%

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, Cyclopentasiloxane, Trimethylsiloxysilicate, Glycerin, PEG-10 Dimethicone, Butylene Glycol, Niacinamide, Cetyl Ethylhexanoate, Pentylene Glycol, Iron Oxides (CI 77492), VP/Hexadecene Copolymer, Caprylyl Methicone, Polypropylsilsesquioxane, Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Iron Oxides (CI 77491), Stearic Acid, Synthetic Fluorphlogopite, Disteardimonium Hectorite, Alumina, Iron Oxides (CI 77499), Acrylates/Dimethicone Copolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica (CI 77019), Tin Oxide (CI 77861), Polyglutamic Acid

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

image description
(click image for full-size original)

JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION MEDIUM
titanium dioxide, octinoxate, octisalate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 131.9 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 67 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
GLYCERIN
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL
NIACINAMIDE
CETYL ETHYLHEXANOATE
PENTYLENE GLYCOL
FERRIC OXIDE YELLOW
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
CAPRYLYL TRISILOXANE
MAGNESIUM SULFATE, UNSPECIFIED FORM
PHENOXYETHANOL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
FERRIC OXIDE RED
STEARIC ACID
DISTEARDIMONIUM HECTORITE
ALUMINUM OXIDE
FERROSOFERRIC OXIDE
TRIETHOXYCAPRYLYLSILANE
ALUMINUM HYDROXIDE
DIMETHICONE
ETHYLHEXYLGLYCERIN
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
ADENOSINE
EDETATE DISODIUM
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)
MICA
STANNIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71261-002-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71261-002-01)
1 NDC:71261-002-01 14 g in 1 CONTAINER This package is contained within the CARTON (71261-002-02)
2 NDC:71261-002-04 2 CONTAINER in 1 CARTON contains a CONTAINER (71261-002-03)
2 NDC:71261-002-03 14 g in 1 CONTAINER This package is contained within the CARTON (71261-002-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/16/2020
Labeler — Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant — Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
Name Address ID/FEI Operations
Cosmax, Inc 689049693 manufacture (71261-002)

Revised: 07/2021 Jungsaemmool Beauty Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.