OTC Medication Information: INCELLDERM 4D LUSTRE CUSHION

INCELLDERM 4D LUSTRE CUSHION- titanium dioxide, octinoxate, octisalate, niacinamide and adenosine powder
Riman Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENTS

Titanium Dioxide 9.18%
Ethylhexyl Methoxycinnamate 7.00%
Ethylhexyl Salicylate 4.80%
Niacinamide 2.0%
Adenosine 0.04%

INACTIVE INGREDIENTS

Water, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Phenyl Trimethicone, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Octyldodecanol, Glycerin, Methylpropanediol, Triethylhexanoin, Polyisobutene, Cetyl Ethylhexanoate, Dimethicone, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Chloride, Mica, Hydrogenated Polyisobutene, Ozokerite, Diphenylsiloxy Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, CI 77492, Stearic Acid, Hyaluronic Acid, Aluminum Hydroxide, Beeswax, Disteardimonium Hectorite, Sorbitan Sesquioleate, Butyrospermum Parkii (Shea) Butter, CI 77491, Xanthan Gum, Fragrance, Polymethyl Methacrylate, Lactobacillus Ferment Lysate, Canola Oil, Propylene Carbonate, Tocopheryl Acetate, Maltodextrin, Saccharide Hydrolysate, Distarch Phosphate, CI 77499, Caprylyl Glycol, Ceramide NP, Anhydroxylitol, Xylitylglucoside, Triethoxycaprylylsilane, Phytosphingosine, Xylitol, Akebia Quinata Extract, Disodium EDTA, Zinc Oxide, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Lithospermum Erythrorhizon Root Extract, Ultramarines, Angelica Dahurica Root Extract, Angelica Gigas Root Extract, Citrus Unshiu Peel Extract, Pichia Anomala Extract, Prunus Armeniaca (Apricot) Kernel Extract, Sesamum Indicum (Sesame) Seed Extract, Xanthium Strumarium Fruit Extract, Centella Asiatica Extract, Daucus Carota Sativa (Carrot) Seed Oil, Hydrogen Dimethicone, Camellia Sinensis Leaf Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Chenopodium Album Flower Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Lactuca Indica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract, Ethylhexylglycerin

PURPOSE

Sunscreen, Skin Brightening, Anti-wrinkle

WARNINGS

1. When or after using cosmetics, consult with a specialist, if you have abnormal symptoms such as red spot, swelling or itching or side effects due to direct sunlight.
2. Do not use in wounded areas.
3. Cautions for storage and handling a) Keep out of reach of children. b) Store away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Protects skin from UV rays. (SPF50 + / PA++++)
Helps skin brightening.
Helps to improve wrinkles of skin.

Directions

Take an appropriate amount and do the dove. Spread softly and wait for absorption.

Questions

http://www.incellderm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton
(click image for full-size original)

INCELLDERM 4D LUSTRE CUSHION
titanium dioxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate, niacinamide, adenosine powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72650-070
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 1.37 g in 15 g
Octinoxate (OCTINOXATE) Octinoxate 1.05 g in 15 g
Octisalate (OCTISALATE) Octisalate 0.72 g in 15 g
Niacinamide (NIACINAMIDE) Niacinamide 0.30 g in 15 g
Adenosine (ADENOSINE) Adenosine 0.006 g in 15 g
Inactive Ingredients
Ingredient Name Strength
Water
Butylene Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72650-070-02 2 CONTAINER in 1 CARTON contains a CONTAINER (72650-070-01)
1 NDC:72650-070-01 15 g in 1 CONTAINER This package is contained within the CARTON (72650-070-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2020
Labeler — Riman Co., Ltd. (694893735)
Registrant — Riman Co., Ltd. (694893735)
Establishment
Name Address ID/FEI Operations
ATEC Co., Ltd. 689276681 manufacture (72650-070)

Revised: 06/2020 Riman 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.

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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.

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