INNISFREE DAILY UV DEFENSE SUNSCREEN- avobenzone, homosalate, and octisalate lotion lotion

innisfree Daily UV Defense Sunscreen by

Drug Labeling and Warnings

innisfree Daily UV Defense Sunscreen by is a Otc medication manufactured, distributed, or labeled by Innisfree Corporation, Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

Avobenzone 2.5%

Homosalate 7.0%

Octisalate 4.3%

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 causes by the sun

Warnings

For external use only

Do not use on damanged 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

WATER / AQUA / EAU, BUTYLOCTYL SALICYLATE, ETHYLHEXYL SALICYLATE, BUTYLENE GLYCOL, ETHYLHEXYL METHOXYCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, POLYMETHYLSILSESQUIOXANE, 1,2-HEXANEDIOL, CETYL ALCOHOL, ARACHIDYL GLUCOSIDE, PHENOXYETHANOL, PROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, OCTYLDODECANOL, GLYCERYL STEARATE, PEG-100 STEARATE, FRAGRANCE / PARFUM, XANTHAN GUM, LIMONENE, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, T-BUTYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, LINALOOL, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, CITRUS UNSHIU PEEL EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, ORCHID EXTRACT, CAMELLIA JAPONICA LEAF EXTRACT, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE

Other information

Protect the product in this container from excessive heat and direct sun.

Questions?

support@us.amorepacific.com

Innisfree Daily UV Defense

Innisfree

DAILY UV

DEFENSE
SUNSCREEN
BROAD SPECTRUM
SPF 36

NO WHITE CAST

GLOWY FINISH

50 mL

1.69 Fl. Oz.

Innisfree Daily UV Defense 100mL

DAILY
UV DEFENSE
SUNSCREEN

BROAD SPECTRUM
SPF 36

NO WHITE CAST

GLOWY FINISH

100mL

3.38 Fl. Oz.

Innisfree Best Seller Mini set - Daily UV Defense 50 mL

Innisfree Best Seller Mini set

PRINCIPAL DISPLAY PANEL

Innisfree

DAILY UV

DEFENSE
SUNSCREEN
BROAD SPECTRUM
SPF 36

NO WHITE CAST

GLOWY FINISH

10 mL
0.33 Fl. Oz.

Innisfree Brighten+Protect set -- Daily UV Defense 25mL

Innisfree

Brighten+Protect

INGREDIENTS AND APPEARANCE

INNISFREE DAILY UV DEFENSE SUNSCREEN 
avobenzone, homosalate, and octisalate lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.15 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
CYCNOCHES COOPERI FLOWERING TOP (UNII: B9BV87G0K5)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
PEG-100 STEARATE (UNII: YD01N1999R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
XANTHAN GUM (UNII: TTV12P4NEE)
PURSLANE (UNII: M6S840WXG5)
DOCOSANOL (UNII: 9G1OE216XY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-086-08	1 in 1 BOX	02/01/2024
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71220-086-40	1 in 1 BOX	07/01/2024
2		100 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71220-086-41	1 in 1 BOX	07/01/2024
3		10 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 71220-086-99	1 in 1 BOX	07/01/2024
4		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2024

Labeler - Innisfree Corporation (557822425)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(71220-086)