Eco Soul Real Fit Makeup Base 01 Green by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Drug Details [pdf]

ECO SOUL REAL FIT MAKEUP BASE 01 GREEN- octinoxate, titanium dioxide, octisalate, zinc oxide cream
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: Ethylhexyl Methoxycinnamate 6.00%, Titanium Dioxide 4.04%, Ethylhexyl Salicylate 2.00%, Zinc Oxide 1.92%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Phenyl Trimethicone, Glycerin, Isopropyl Isostearate, Pentaerythrityl Tetraisostearate, PEG-10 Dimethicone, Talc, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Aluminum Hydroxide, Aluminum Stearate, Niacinamide, Disteardimonium Hectorite, Magnesium Sulfate, Acrylates/Dimethicone Copolymer, Betaine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, C12-14 Pareth-3, Phenoxyethanol, Chromium Oxide Greens, Palmitic Acid, Fragrance, Ethylhexylglycerin, Tocopheryl Acetate, Hydroxyethylcellulose, Adenosine, Ultramarines (CI 77007), Rhododendron Ferrugineum Extract, Amorphophallus Konjac Root Extract, Thymus Vulgaris (Thyme) Extract, Buddleja Davidii Extract, Oxygen, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rosmarinus Officinalis (Rosemary) Extract

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:

Use after your skincare routine. Apply an appropriate amount evenly on the face along skin's texture and gently tap for better coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton

ECO SOUL REAL FIT MAKEUP BASE 01 GREEN
octinoxate, titanium dioxide, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-634
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.40 g in 40 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.61 g in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.80 g in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.76 g in 40 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-634-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-634-01	40 mL 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
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(70341-634)

Revised: 12/2019

Document Id: d9c157ff-de52-4a10-84e2-641b36ed96ab

Set id: c6789fc7-41df-4cfb-ab81-0503f894cc00

Version: 2

Effective Time: 20191227

The Saem International Co., Ltd.