Eco Soul Skin Wear BB 21 by The Saem International Co., Ltd. / Hanacos Co., Ltd.

Drug Details [pdf]

ECO SOUL SKIN WEAR BB 21- titanium dioxide, octinoxate, 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: Titanium Dioxide 9.45%, Ethylhexyl Methoxycinnamate 7.50%, Zinc Oxide 7.00%

INACTIVE INGREDIENT

Inactive ingredients:

Eucalyptus Globulus Leaf Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Arbutin, Dimethicone, Sodium Chloride, Beeswax, CI 77492, Magnesium Aluminum Silicate, Nylon-12, Stearalkonium Hectorite, Phenoxyethanol, CI 77491, Dimethicone/Vinyl Dimethicone Crosspolymer, Ozokerite, Pentylene Glycol, Fragrance, PEG-10 Dimethicone Crosspolymer, 1,2-Hexanediol, Caprylyl Glycol, Water, CI 77499, Triethoxycaprylylsilane, Adenosine, Aluminum Hydroxide, Caprylic/Capric Triglyceride, Glycerin, Alcohol, Artemisia Absinthium Extract, Chamomilla Recutita (Matricaria) Flower Extract, Gentiana Lutea Root Extract, Portulaca Oleracea Extract, Chamaecyparis Obtusa Leaf Extract, Origanum Vulgare Leaf Extract, Salix Alba (Willow) Bark Extractm, Acer Saccharum (Sugar Maple) Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Lecithin, Polyglutamic Acid, Saccharide Isomerate, Scutellaria Baicalensis Root Extract, Ceramide NP, Creatine, Sodium Ascorbyl Phosphate, Disodium EDTA

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 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 SKIN WEAR BB 21
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-643
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.78 g in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.00 g in 40 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.80 g in 40 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-643-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-643-01	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
HANACOS CO., LTD.		690177857	manufacture(70341-643)

Revised: 12/2019

Document Id: 756fac16-2159-4281-904a-84cfff058cef

Set id: 221af545-82ec-4499-aa44-d3b77cfe2ec4

Version: 2

Effective Time: 20191228