SHEA BUTTER STEAM FRESH by NATURE REPUBLIC CO., LTD. / Cosmax, Inc.

SHEA BUTTER STEAM FRESH by

Drug Labeling and Warnings

SHEA BUTTER STEAM FRESH 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]

SHEA BUTTER STEAM FRESH- glycerin cream 
NATURE REPUBLIC 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.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 15.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Butylene Glycol, Sodium Chloride, Pentaerythrityl Tetraethylhexanoate, Pentylene Glycol, PEG-10 Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-17/6 Copolymer, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Phenoxyethanol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disodium EDTA, Fragrance(Parfum), Dipotassium Glycyrrhizate, Butyrospermum Parkii (Shea) Butter, Sea Water, 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, 1,2-Hexanediol, Origanum Majorana Leaf Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Aurantifolia (Lime) Fruit Extract, Cymbopogon Schoenanthus Extract, Melissa Officinalis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Pelargonium Graveolens Extract, Mentha Rotundifolia Leaf Extract, Origanum Vulgare Leaf Extract, Eucalyptus Globulus Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Mentha Spicata Flower/Leaf/Stem Extract, Rubus Chamaemorus Seed Extract, Ethylhexylglycerin

PURPOSE

Purpose: [SKIN PROTECTANT] This fresh cream combines shea butter with hot steam technology for oily and combination skin.

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

SHEA BUTTER STEAM FRESH 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-356
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	15 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: 51346-356-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	10/01/2015	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2015	02/01/2020

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(51346-356)

Revised: 2/2020

Document Id: fc241efa-1738-4d8c-9d23-7b930ffb0abf

34390-5

Set id: 276e3bff-d929-4ee3-8818-d68bd5ce00cb

Version: 3

Effective Time: 20200225

 

NATURE REPUBLIC CO., LTD.