DITOPI PROTEIN- dimethicone lotion 
PROSTEMICS 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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ACTIVE INGREDIENT

Active Ingredient: DIMETHICONE 1.5%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, GLYCERIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL, PALMITIC ACID, STEARIC ACID, POLYSORBATE 60, GLYCERYL STEARATE, PEG-100 STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM HYALURONATE, SORBITAN SESQUIOLEATE, BEESWAX, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, CAPRYLYL GLYOCOL, ETHYLHEXYLGLYCERIN, UNDARIA PINNATIFIDA EXTRACT, PORTULACA OLERACEA EXTRACT, BETULA PLATYPHYLLA JAPONICA JUICE, CETEARYL ALCOHOL, BAMBUSA VULGARIS EXTRACT, PINUS DENSKFLORA EXTRACT, THUJA ORIENTALIS EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, CAMELLIA JAPONICA SEED OIL, EMU OIL, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, CERAMIDE 3, MACADAMIA TERNIFOLIA SEED OIL, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, MINERAL OIL, POLYSORBATE60, 1,2-HEXANEDIOL, 1,2-OCTANEDIOL, PROPYLENE GLYCOL, CARBOMER, POTASSIUM HYDROXIDE, HYDROXYPROPYL STARCH PHOSPHATE, FRAGRANCE

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of infants or children's reach.

INDICATIONS & USAGE

Indication and Usage: 1. Always keep a tight lid after use. 2. Do not put it in extremely hot or cold places or where exposed to direct sunlight. 3. Daily ditopi skin care for very dry, sensitive skin conditions that nourishes, restores the skin barrier, reduces hypersensitivity and soothes skin irritation.

DOSAGE & ADMINISTRATION

Dosage and Administration: After use of ditopi Body Cleanser, take appropriate amount of the lotion and apply it evenly and massage it very lightly all over the face and body. Use it every morning and night as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DITOPI PROTEIN 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4.50 mg  in 300 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62041-120-01300 mL in 1 CARTON; Type 0: Not a Combination Product07/01/201511/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/201511/01/2018
Labeler - PROSTEMICS Co., Ltd. (689605919)
Registrant - PROSTEMICS Co., Ltd. (689605919)
Establishment
NameAddressID/FEIBusiness Operations
PROSTEMICS Co., Ltd.689605919manufacture(62041-120)

Revised: 2/2019
 
PROSTEMICS Co., Ltd.