Eco Soul Spau BB 01 Light Beige by The Saem International Co., Ltd.

Eco Soul Spau BB 01 Light Beige by

Drug Labeling and Warnings

Eco Soul Spau BB 01 Light Beige by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO SOUL SPAU BB 01 LIGHT BEIGE- titanium dioxide, octinoxate, octisalate gel 
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 8.15%, Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 3.0%,

INACTIVE INGREDIENT

Inactive Ingredients: Onsen-Sui, Glycerin, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Squalane, Niacinamide, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, Pentylene Glycol, Iron Oxides (CI 77492), Triceteareth-4 Phosphate, Glycol Stearate, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Potassium Cetyl Phosphate, Polysorbate 60, PEG-10 Dimethicone, PEG-2 Stearate, PEG-100 Stearate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Stearate, Water, Carbomer, Isohexadecane, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Caprylyl Glycol, 1,2-Hexanediol, Tromethamine, Iron Oxides (CI 77499), Polysorbate 80, Ethylhexylglycerin, Adenosine, Aluminum Hydroxide, Disodium EDTA, Silica, Nelumbo Nucifera Flower Water, Centaurea Cyanus Flower Water, Rosa Centifolia Flower Water, Polydecene, Imperata Cylindrica Root Extract, Aqua, Sodium Hyaluronate, Madecassoside, PEG-8, Viscum Album (Mistletoe) Fruit Extract, Camellia Japonica Flower Extract, Marrubium Vulgare Extract, Lavandula Angustifolia (Lavender) Flower Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Agave Tequilana Leaf Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Monarda Didyma Leaf Extract, Sodium Benzoate, Citric Acid, Potassium Sorbate, Anthemis Nobilis Flower Extract, Rosa Canina Fruit Extract, Rumex Acetosella Extract, Rose Extract, Carthamus Tinctorius (Safflower) Flower Extract, Hibiscus Sabdariffa Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: 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.

Keep out of reach of Children: Keep out of reach of babies and children

DESCRIPTION

Indication & Usage: After skin care procedure or makeup base, apply adequate amount on skin gently.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

ECO SOUL SPAU BB 01 LIGHT BEIGE 
titanium dioxide, octinoxate, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.26 g  in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.80 g  in 40 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.20 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-250-0140 mL in 1 CARTON; Type 0: Not a Combination Product12/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201511/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-250)

Revised: 12/2019
 
The Saem International Co., Ltd.