Saemmul A Clean BB by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Drug Details [pdf]

SAEMMUL A CLEAN BB- 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 7.92%, ETHYLHEXYL METHOXYCINNAMATE 3.00%, ZINC OXIDE 1.92%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Talc, Glycerin, Methylpropanediol, Cyclomethicone, PEG-10 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Betaine, Triethylhexanoin, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycosyl Trehalose, Iron Oxides(CI 77492), Phenoxyethanol, Acrylates/Dimethicone Copolymer, Hydrogenated Starch Hydrolysate, Methicone, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Palmitic Acid, Ethylhexylglycerin, Portulaca Oleracea Extract, Tocopheryl Acetate, Fragrance, Aluminum Hydroxide, Aluminum Stearate, Dimethicone, Butylene Glycol, Madecassoside, Aloe Barbadensis Leaf Water, Prunus Armeniaca (Apricot) Kernel Oil, Rosa Centifolia Flower Water, Tilia Vulgaris Flower Extract, Betula Alba Juice, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Benzyl Alcohol, Dehydroacetic Acid, 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 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

SAEMMUL A CLEAN BB
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-619
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.18 g in 15 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.45 g in 15 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.28 g in 15 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: 70341-619-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-619-01	15 mL in 1 TUBE; 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(70341-619)

Revised: 12/2019

Document Id: 98132de9-0195-4af4-ba7e-4ddd51aff5cb

Set id: 147f5ea2-f519-4d42-83c8-73e34d5585d5

Version: 2

Effective Time: 20191230

The Saem International Co., Ltd.