MISSHA M RADIANCE TWO WAY PACT SPF27 NO21- titanium dioxide, zinc oxide, octinoxate powder 
MISSHA M RADIANCE TWO WAY PACT SPF27 NO23- titanium dioxide, zinc oxide, octinoxate powder 
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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MISSHA M RADIANCE TWO WAY PACT SPF27

ACTIVE INGREDIENTS

Titanium Dioxide 9.1%

Zinc Oxide 3.9%

Octinoxate 3.5%

PURPOSE

Sunscreen

Uses

  • helps prevent sunburn

  • if used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to Remove.

Stop use and ask a doctor

If rash occurs

Keep out of reach of children

if swalled, get medical help or contact Poson Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure

  • reapply at least every 2 hours

  • use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m. – 2p.m.

  • wear long-sleeved shirts, pants, hats and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENTS

Mica, Talc, Nylon-12, Silica, Boron Nitride, Dimethicone, Triethylhexanoin, Phenyl Trimethicone, Alumina, Ethylene/Acrylic Acid Copolymer, Magnesium Stearate, Iron Oxides (CI 77492), Methyl Methacrylate Crosspolymer, Magnesium Myristate, Methicone, Ethylhexylglycerin, Hydrogenated Lecithin, Glyceryl Caprylate, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Montmorillonite, Fragrance(Parfum), Triethoxycaprylylsilane, Ultramarines, Butylene Glycol, Water, Diamond powder, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Polymethylsilsesquioxane, PVP, Haematococcus Pluvialis Extract, Astaxanthin, Phenoxyethanol, Fullerenes, Platinum Powder

Questions or comments?

Visit www.misshaus.com or call 1-888-985-9887 ext.104

MISSHA M RADIANCE TWO WAY PACT SPF27 NO 21

MRadianceTwowayPact21R

MISSHA M RADIANCE TWO WAY PACT SPF27 NO 23

MRAdianceTwowayPact23R

MISSHA M RADIANCE TWO WAY PACT SPF27 NO21 
titanium dioxide, zinc oxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-209
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.05 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.92 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
TALC (UNII: 7SEV7J4R1U)  
NYLON-12 (UNII: 446U8J075B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHYL METHACRYLATE (UNII: 196OC77688)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MONTMORILLONITE (UNII: A585MN1H2L)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
DIAMOND (UNII: 6GRV67N0U2)  
ALMOND (UNII: 3Z252A2K9G)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
ASTAXANTHIN (UNII: 8XPW32PR7I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUCKMINSTERFULLERENE (UNII: NP9U26B839)  
PLATINUM (UNII: 49DFR088MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-209-0111 g in 1 CONTAINER; Type 0: Not a Combination Product06/01/201610/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201610/27/2018
MISSHA M RADIANCE TWO WAY PACT SPF27 NO23 
titanium dioxide, zinc oxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.05 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.92 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
TALC (UNII: 7SEV7J4R1U)  
NYLON-12 (UNII: 446U8J075B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHYL METHACRYLATE (UNII: 196OC77688)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MONTMORILLONITE (UNII: A585MN1H2L)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
WATER (UNII: 059QF0KO0R)  
DIAMOND (UNII: 6GRV67N0U2)  
ALMOND (UNII: 3Z252A2K9G)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
ASTAXANTHIN (UNII: 8XPW32PR7I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUCKMINSTERFULLERENE (UNII: NP9U26B839)  
PLATINUM (UNII: 49DFR088MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-210-0111 g in 1 CONTAINER; Type 0: Not a Combination Product06/01/201610/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201610/27/2018
Labeler - Able C&C Co., Ltd. (689540284)
Registrant - Able C&C Co., Ltd. (689540284)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(13733-209, 13733-210)

Revised: 10/2018
 
Able C&C Co., Ltd.