CLEAR IT UP ACNE CARE KIT WITH BIJA SEED OIL- salicylic acid
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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Clear it up! Acne care kit with bija seed oil

Drug Facts

Active ingredient

Salicylic Acid (0.6%)

Purpose

Acne treatment

Uses

For the treatment of acne.
Helps clear up acne blemishes and allows skin to heal
Penetrates pores to control acne pimples
Helps prevent new acne blemishes, pimples from forming

Warnings

For external use only.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at the same time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

cleanse skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
because excessive drying of the skin may occur, start with one application daily then gradually increase to two or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store at room temperature.

Inactive ingredients

water, propanediol, squalane, cyclopentasiloxane, cyclohexasiloxane, glyceryl stearate, niacinamide, cetyl alcohol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, octyldodecanol, silica, torreya nucifera seed oil, cetearyl alcohol, peg-100 stearate, tromethamine, peg-75 stearate, fragrance, xanthan gum, polyacrylate-13, ceteth-20, steareth-20, glyceryl caprylate, polyisobutene, ethylhexylglycerin, camellia japonica leaf extract, camellia sinensis leaf extract, citrus unshiu peel extract, opuntia coccinellifera fruit extract, orchid extract, disodium edta, polysorbate 20, sorbitan isostearate

PRINCIPAL DISPLAY PANEL - Kit Carton

Clear it up!

Acne care
with bija seed oil

innisfree

3.71 FL. OZ./110ml

CLEAR IT UP ACNE CARE KIT WITH BIJA SEED OIL
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71220-076

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71220-076-12	1 in 1 CARTON	05/01/2018	10/14/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	50 mL
Part 2	1 TUBE	20 mL
Part 3	1 BOTTLE	30 mL
Part 4	1 TUBE	10 mL

Part 1 of 4

BLEMISH CARE EMULSION WITH BIJA SEED OIL
salicylic acid lotion

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.3 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TORREYA NUCIFERA SEED OIL (UNII: 33JR96IW2B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
TROMETHAMINE (UNII: 023C2WHX2V)
PEG-75 STEARATE (UNII: OT38R0N74H)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
SQUALANE (UNII: GW89575KF9)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	05/01/2018

Part 2 of 4

CLARIFYING FACIAL FOAM WITH BIJA SEED OIL
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	MYRISTIC ACID (UNII: 0I3V7S25AW)
INGR	POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
INGR	POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	LAURIC ACID (UNII: 1160N9NU9U)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	TORREYA NUCIFERA SEED OIL (UNII: 33JR96IW2B)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	COCOA (UNII: D9108TZ9KG)
INGR	ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
INGR	LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
INGR	CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	TANGERINE PEEL (UNII: JU3D414057)
INGR	OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		20 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Part 3 of 4

INTENSIVE HYDRATING SERUM WITH GREEN TEA SEED
face and neck (excluding shaving preparations) lotion

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	DIETHOXYETHYL SUCCINATE (UNII: R1B8ZV94R9)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BETAINE (UNII: 3SCV180C9W)
INGR	PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
INGR	C12-16 ALCOHOLS (UNII: S4827SZE3L)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
INGR	CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
INGR	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	PALMITIC ACID (UNII: 2V16EO95H1)
INGR	OCTYLDODECETH-16 (UNII: RJV574G0DE)
INGR	POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
INGR	TANGERINE PEEL (UNII: JU3D414057)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	COCOA (UNII: D9108TZ9KG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Part 4 of 4

CICA BALM WITH BIJA SEED OIL
face and neck (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	C12-16 ALCOHOLS (UNII: S4827SZE3L)
INGR	DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	TROMETHAMINE (UNII: 023C2WHX2V)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	PALMITIC ACID (UNII: 2V16EO95H1)
INGR	CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INGR	TORREYA NUCIFERA SEED OIL (UNII: 33JR96IW2B)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	MADECASSOSIDE (UNII: CQ2F5O6YIY)
INGR	ASIATICOSIDE (UNII: PKO39VY215)
INGR	CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	TANGERINE PEEL (UNII: JU3D414057)
INGR	OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
INGR	MADECASSIC ACID (UNII: M7O1N24J82)
INGR	ASIATIC ACID (UNII: 9PA5A687X5)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	05/01/2018	10/14/2019

Labeler - Innisfree Corporation (557822425)

Name	Address	ID/FEI	Business Operations
Establishment
COSVISION		557789645	manufacture(71220-076)

Revised: 10/2019

Document Id: 94f4ff8c-7244-298b-e053-2995a90ac7b1

Set id: d0030779-04a1-45aa-9913-08fcd348e05d

Version: 4

Effective Time: 20191015

Innisfree Corporation