INNISFREE MATTE FULL-COVER CUSHION W39 DEEP TAN- zinc oxide, octinoxate, and titanium dioxide lotion 
INNISFREE MATTE FULL-COVER CUSHION W41 CINNAMON- zinc oxide, octinoxate, and titanium dioxide lotion 
Innisfree Corporation

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.

----------

innisfree Matte Full-cover Cushion

Drug Facts

Active ingredientsPurpose
Zinc Oxide 7.84%Sunscreen
Octinoxate 7%Sunscreen
Titanium Dioxide 3.32%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

Warnings

  • For external use only

  • 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 product is swallowed, get medical help or contact a Poison 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • children under 6 months of age: Ask a doctor

Inactive ingredients

BUTYLENE GLYCOL DICAPRYLATE/ DICAPRATE, METHYL METHACRYLATE CROSSPOLYMER, IRON OXIDES (CI 77492), DIMETHICONE, BORON NITRIDE, IRON OXIDES (CI 77491), DEXTRIN PALMITATE, TITANIUM DIOXIDE (CI 77891), MICROCRYSTALLINE WAX / CERA MICROCRISTALLINA / CIRE MICROCRISTALLINE, POLYBUTENE, IRON OXIDES (CI 77499), POLYHYDROXYSTEARIC ACID, ETHYLHEXYL PALMITATE, ISOPROPYL PALMITATE, ISOSTEARIC ACID, LECITHIN, ALUMINUM HYDROXIDE, STEARIC ACID, FRAGRANCE / PARFUM, POLYGLYCERYL-3 POLYRICINOLEATE, CAPRYLYL GLYCOL, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, GLYCERYL CAPRYLATE, MINERAL SALTS, WATER / AQUA / EAU, PROPANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, CITRUS TANGERINA (TANGERINE) EXTRACT, LACTIC ACID, ASCORBIC ACID, CITRIC ACID

Other information

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

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W39 Deep tan

innisfree

MATTE FULL-COVER CUSHION
broadspectrum SPF 50+

NET WT. 0.49 OZ. / 14 g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W39 Deep tan

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W41 Cinnamon

innisfree

MATTE FULL-COVER CUSHION
broadspectrum SPF 50+

NET WT. 0.49 OZ. / 14 g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W41 Cinnamon
INNISFREE MATTE FULL-COVER CUSHION W39 DEEP TAN 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71220-079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.09 g  in 14 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.98 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.45 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
TANGERINE (UNII: KH3E3096OO)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71220-079-011 in 1 CARTON08/01/201810/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201810/14/2019
INNISFREE MATTE FULL-COVER CUSHION W41 CINNAMON 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71220-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.09 g  in 14 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.98 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.45 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
TANGERINE (UNII: KH3E3096OO)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71220-080-011 in 1 CARTON08/01/201810/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201810/14/2019
Labeler - Innisfree Corporation (557822425)
Establishment
NameAddressID/FEIBusiness Operations
COSVISION557789645manufacture(71220-079, 71220-080)

Revised: 10/2019
Document Id: 94fd435e-9493-1b70-e053-2a95a90a2d5e
Set id: 6ef9b4ad-a74c-45e0-98cb-a342d268817e
Version: 3
Effective Time: 20191015
 
Innisfree Corporation