matte full cover cushion

Drug Labeling and Warnings

Drug Details [pdf]

MATTE FULL COVER CUSHION C11- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION C13- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION C21- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION N21- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION W21- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION N23- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION W23- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION N27- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION N31- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION W33- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION W34- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION W35- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION W37- octinoxate, titanium dioxide, and zinc oxide lotion 
MATTE FULL COVER CUSHION C43- octinoxate, titanium dioxide, and zinc oxide 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.

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matte full cover cushion

Drug Facts

Active ingredientsPurpose
Octinoxate 7%Sunscreen
Titanium Dioxide 3.32%Sunscreen
Zinc Oxide 7.84%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, TITANIUM DIOXIDE (CI 77891), METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE, BORON NITRIDE, DEXTRIN PALMITATE, MICROCRYSTALLINE WAX, POLYBUTENE, POLYHYDROXYSTEARIC ACID, IRON OXIDES (CI 77492), ETHYLHEXYL PALMITATE, IRON OXIDES (CI 77491), ISOPROPYL PALMITATE, ISOSTEARIC ACID, LECITHIN, ALUMINUM HYDROXIDE, STEARIC ACID, FRAGRANCE, POLYGLYCERYL-3 POLYRICINOLEATE, CAPLYLYL GLYCOL, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, GLYCERYL CAPRYLATE, MINERAL SALTS, WATER, IRON OXIDES (CI 77499), 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 - C11 Cool ivory

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C11 Cool ivory

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C13 Light beige

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C13 Light beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C21 Pink beige

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C21 Pink beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N21 Natural beige

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N21 Natural beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W21 Warm beige

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W21 Warm beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N23 True beige

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N23 True beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W23 Golden beige

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W23 Golden beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N27 Sand

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N27 Sand

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N31 Walnut

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N31 Walnut

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W33 Chestnut

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W33 Chestnut

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W34 Golden caramel

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W34 Golden caramel

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W35 Golden cinnamon

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W35 Golden cinnamon

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W37 Golden tan

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W37 Golden tan

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C43 Chocolate

innisfree

MATTE FULL-COVER CUSHION

broadspectrum SPF 50+

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C43 Chocolate
MATTE FULL COVER CUSHION C11 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-041-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION C13 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-042-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION C21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-043-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION N21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-044-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION W21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-045-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION N23 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-046-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION W23 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-047-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION N27 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-048-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION N31 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-049-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION W33 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-050-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION W34 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-051-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION W35 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-052-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION W37 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-053-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
MATTE FULL COVER CUSHION C43 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.32 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.84 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
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: 71220-054-011 in 1 CARTON06/23/201710/14/2019
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 finalpart35206/23/201710/14/2019
Labeler - Innisfree Corporation (557822425)
Establishment
NameAddressID/FEIBusiness Operations
COSVISION557789645manufacture(71220-041, 71220-042, 71220-043, 71220-044, 71220-045, 71220-046, 71220-047, 71220-048, 71220-049, 71220-050, 71220-051, 71220-052, 71220-053, 71220-054)

Revised: 10/2019
 
Innisfree Corporation