FINE FINISH PRESSED POWDER C13- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER C21- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER N21- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER W21- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER N23- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER W23- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER C27- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER N27- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER N31- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER W31- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER N33- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER W35- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER W37- octinoxate, titanium dioxide, and zinc oxide lotion
FINE FINISH PRESSED POWDER 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.

----------

fine finish pressed powder

Drug Facts

Active ingredients	Purpose
Octinoxate 3.19776%	Sunscreen
Titanium Dioxide 4.268%	Sunscreen
Zinc Oxide 1.96%	Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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
children under 6 months of age: Ask a doctor

Inactive ingredients

TALC, BORON NITRIDE, SILICA, MICA, ETHYLENE/ACRYLIC ACID COPOLYMER, POLYMETHYL METHACRYLATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PEG-10 DIMETHICONE, IRON OXIDES (CI 77492), METHICONE, ETHYLHEXYLGLYCERIN, IRON OXIDES (CI 77491), LAUROYL LYSINE, FRAGRANCE, GLYCERYL CAPRYLATE, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77499), WATER, MINERAL SALTS, GLYCERIN, BHT, BUTYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, CITRUS UNSHIU PEEL EXTRACT, CAMELLIA JAPONICA LEAF EXTRACT, ORCHID EXTRACT, PHENOXYETHANOL

Other information

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

FINE FINISH PRESSED POWDER C13
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
TANGERINE PEEL (UNII: JU3D414057)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-013-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER C21
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-014-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER N21
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
TANGERINE PEEL (UNII: JU3D414057)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-015-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER W21
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-016-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER N23
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-017-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER W23
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-018-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER C27
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-019-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER N27
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-020-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER N31
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-021-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER W31
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-022-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER N33
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-023
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-023-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER W35
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-024
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-024-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER W37
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-025
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-025-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

FINE FINISH PRESSED POWDER C43
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.19776 g in 13 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.268 g in 13 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 13 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BORON NITRIDE (UNII: 2U4T60A6YD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAUROYL LYSINE (UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-026-02	1 in 1 CARTON	06/23/2017	09/16/2019
1		13 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/23/2017	09/16/2019

Labeler - Innisfree Corporation (557822425)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea		689512611	manufacture(71220-013, 71220-014, 71220-015, 71220-016, 71220-017, 71220-018, 71220-019, 71220-020, 71220-021, 71220-022, 71220-023, 71220-024, 71220-025, 71220-026)

Revised: 12/2019

Document Id: 997354c8-00f4-c9dd-e053-2a95a90a3071

Set id: c474707c-b4b5-42f6-9350-e6e84d2b6f36

Version: 2

Effective Time: 20191211

Innisfree Corporation