MISSHA M SWIRL BB SUN BALM SPF50 PLUS PA PLUS PLUS PLUS NO.21- titanium dioxide cream 
ABLE C&C 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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Drug Facts

ACTIVE INGREDIENTS: Titanium Dioxide 22.3%, Zinc Oxide 7.2%

INACTIVE INGREDIENTS:
Dimethicone,Triethylhexanoin, Phenyl Trimethicone, Butylene Glycol Dicaprylate/Dicaprate, Cyclomethicone, Polyethylene, Orbignya Oleifera Seed Oil, Bis-PEG-18 Methyl Ether Dimethyl Silane, Caprylic/Capric Triglyceride, Ozokerite, Mica, Sorbitan Olivate, Polymethyl Methacrylate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Trimethylsiloxysilicate, PEG-10 Dimethicone, Magnesium Silicate, Manganese Violet, Dimethiconol, Stearic Acid, Stearalkonium Hectorite, Aluminum Hydroxide, Tocopheryl Acetate, Propylene Carbonate, Cyclotetrasiloxane, Chenopodium Quinoa Seed Extract, Argania Spinosa Kernel Oil, Euterpe Oleracea Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Adansonia Digitata Seed Extract, Equisetum Arvense Extract, Olea Europaea (Olive) Leaf Extract, Sophora Japonica Flower Extract, Fructan, Chrysanthemum Indicum flower Extract, Camellia Sinensis Leaf Extract, Cinnamomum Cassia Bark Extract, Morus Alba Fruit Extract, Artemisia princeps Leaf Extract, Diospyros Kaki Leaf Extact, Pueraria Lobata Root Extract, Codonopsis Lanceolata Root Extract, Panax Ginseng Root Extract, Scrophularia Buergeriana Root Extract, Sophora Angustifolia Root Extract, Salvia Miltiorrhiza Root Extract, Moringa Pterygosperma Seed Oil, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea Butter), Olea Europaea (Olive) Husk Oil, Talc, Triethoxycaprylylsilane, Caprylyl Glycol, Ethylhexylglycerin, 1,2-Hexanediol

PURPOSE:
This combination of Cosmetic / OTC Drug can be used as a sun protection cream and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

WARNINGS:
For external use only.
Do not swallow.
Avoid contact with eyes.
Do not use on wounds or if you are allergic to any ingredients of this product.

Keep out of reach of children:
Keep out of reach of children.

INDICATION AND USAGE:
Take an appropriate amount onto encased puff and apply evenly over the face with skin texture.
Press lightly to the skin for better adherence.

DOSAGE AND ADMINISTRATION:
Take appropriate amount according to your skin condition and apply as you desire.
Remove it before sleeping.

Image of carton

MISSHA M SWIRL BB SUN BALM  SPF50 PLUS PA PLUS PLUS PLUS NO.21
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-012
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.46 g  in 20 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.44 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
BABASSU OIL (UNII: 8QSB4M5477)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICA (UNII: V8A1AW0880)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-012-0120 g in 1 CARTON; Type 0: Not a Combination Product06/01/201112/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/201112/09/2018
Labeler - ABLE C&C CO., LTD. (689540284)
Registrant - ABLE C&C CO., LTD. (689540284)

Revised: 1/2019
 
ABLE C&C CO., LTD.