SHEA BUTTER STEAM ULTRA- dimethicone cream

SHEA BUTTER STEAM ULTRA by

Drug Labeling and Warnings

SHEA BUTTER STEAM ULTRA by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butyrospermum Parkii (Shea) Butter, Hydrogenated Poly(C6-14 Olefin), Glycerin, Dipropylene Glycol, Butylene Glycol, Caprylic/Capric/Myristic/Stearic Triglyceride, Cyclopentasiloxane, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Synthetic Beeswax, Macadamia Integrifolia Seed Oil, Glyceryl Stearate, Methyl Glucose Sesquistearate, Pentylene Glycol, PEG-100 Stearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Arginine, Carbomer, Caprylyl Glycol, Fragrance(Parfum), Tocopheryl Acetate, Disodium EDTA, Sea Water, Borago Officinalis Seed Oil, Bertholletia Excelsa Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Vaccinium Angustifolium (Blueberry) Fruit Extract, Sambucus Nigra Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Portulaca Oleracea Extract, Rubus Idaeus (Raspberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Hippophae Rhamnoides Fruit Extract, Phenoxyethanol, Potassium Sorbate, Citric Acid, 1,2-Hexanediol, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Chamaemorus Seed Extract, Cucurbita Pepo (Pumpkin) Seed Extract, Ethylhexylglycerin

PURPOSE

Purpose: [SKIN PROTECTANT]

Cautions

Cautions: 1. For external use only 2. Avoid contact with eyes and mouth 3. Discontinue use if signs of irritation or rashes appear 4. Keep out of reach of children 5. Replace the cap after use

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

How to use

How to use: At the last step of skin care, apply an appropriate amount to the entire face, and gently pat for absorption.

How to use

How to use: At the last step of skin care, apply an appropriate amount to the entire face, and gently pat for absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHEA BUTTER STEAM ULTRA 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.0 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-354-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2015

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-354)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(51346-354)