SAEMMUL PONGDANG JELL BB- titanium dioxide, octinoxate 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 7.16%, Ethylhexyl Methoxycinnamate 4.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Niacinamide, Pentylene Glycol, Silica, Iron Oxides (CI 77492), Triceteareth-4 Phosphate, Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 60, Phenoxyethanol, PEG-2 Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-10 Dimethicone, PEG-100 Stearate, Tromethamine, Aluminum Hydroxide, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Fragrance(Parfum), PEG-240/HDI Copolymer Bis-Decyltetradeceth-20 Ether, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Betula Platyphylla Japonica Juice, Rosa Centifolia Flower Water, Caprylic/Capric Triglyceride, Caprylyl Glycol, Phalaenopsis Amabilis Extract, Dendrobium Phalaenopsis Flower Extract, Camellia Japonica Flower Extract, Lilium Candidum Bulb Extract, Hibiscus Rosa-Sinensis Flower/Leaf 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. Take an appropriate amount with applicator and apply evenly on the face along skin's texture and gently tap for better coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

SAEMMUL PONGDANG JELL BB 
titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.79 g  in 25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.00 g  in 25 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-616-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-616-0125 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/201811/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(70341-616)

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