Eco Soul Essence Cushion All Cover 21 by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd

Drug Details [pdf]

ECO SOUL ESSENCE CUSHION ALL COVER 21- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
The Saem International 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 ingredients: Titanium Dioxide 9.00%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.80%, Octocrylene 2.00%, Zinc Oxide 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Rosa Damascena Flower Water, 1,2-Hexanediol, Cyclohexasiloxane, Aluminum Hydroxide, Triethoxycaprylylsilane, Bis-Diglyceryl Polyacyladipate-2, PEG-10 Dimethicone, Dimethicone, PEG-30 Dipolyhydroxystearate, Niacinamide, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, C12-15 Alkyl Benzoate, Canola Oil, Sodium Chloride, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, CI 77492, Copernicia Cerifera (Carnauba) Wax, Trimethylsiloxysilicate, Menthone Glycerin Acetal, Chlorphenesin, CI 77491, Aloe Ferox Leaf Extract, Butylene Glycol, Parfum, CI 77499, Adenosine, Water, Caprylyl Glycol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

4. Keep out of reach of babies and children.

DESCRIPTION

Uses:

Helps prevent sunburn.

Directions:

Apply appropriate amount on a puff and gently apply on the entire face followed by skin texture, tap lightly to finish.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ECO SOUL ESSENCE CUSHION ALL COVER 21
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-662
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.17 g in 13 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.91 g in 13 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.62 g in 13 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	0.26 g in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.26 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
1,2-Hexanediol (UNII: TR046Y3K1G)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-662-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-662-01	13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2018	11/01/2019

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Name	Address	ID/FEI	Business Operations
Establishment
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-662)

Revised: 12/2019

Document Id: 65ea3c8f-435d-4074-aef4-aaca175fb53e

Set id: 3ed037ac-8599-4892-81cb-41a11b0c0e79

Version: 2

Effective Time: 20191227

The Saem International Co., Ltd.