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 cartonImage of carton

SAEMMUL A CLEAN BB 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-619
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.18 g  in 15 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.45 g  in 15 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.28 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-619-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-619-0115 mL 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
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70341-619)

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