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. 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, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, BUTYLOCTYL SALICYLATE, ETHYLHEXYL METHOXYCRYLENE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, CETYL ALCOHOL, ARACHIDYL GLUCOSIDE, PHENOXYETHANOL, PROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, OCTYLDODECANOL, FRAGRANCE / PARFUM, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, T-BUTYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, 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

1.69 Fl. Oz. / 50 mL

Innisfree Daily UV Defense - deluxe sample

innisfree

Daily

UV Defense

Sunscreen

Broad Spectrum SPF 36

0.33 Fl. Oz. / 10 mL

Innisfree Daily UV Defense - 100mL Jumbo

Innisfree

Daily

UV Defense

Sunscreen

Broad Spectrum SPF 36

3.38 Fl. Oz. /100 mL

innisfree Daily UV Defense Sunscreen 50mL - limited edition

innisfree

Daily

UV Defense

Broad Spectrum SPF 36

1.69 Fl. Oz. / 50 mL

innisfree Daily UV Defense Sunscreen 1mL - Blister Pack

innisfree

Daily UV Defense

Sunscreen

Braod Spectrum SPF 36

0.03 Fl. Oz. / 1 mL

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: 71220-082
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
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DOCOSANOL (UNII: 9G1OE216XY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETYL ALCOHOL (UNII: 936JST6JCN)
PURSLANE (UNII: M6S840WXG5)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
TANGERINE PEEL (UNII: JU3D414057)
PHANERA VARIEGATA WHOLE (UNII: B11919964F)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PROPANEDIOL (UNII: 5965N8W85T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PEG-100 STEARATE (UNII: YD01N1999R)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-082-09	1 in 1 BOX	03/01/2020	06/10/2025
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71220-082-10	1 in 1 BOX	05/01/2022	12/21/2023
2		50 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71220-082-36	1 in 1 BOX	12/01/2021	08/31/2024
3		10 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 71220-082-37	1 mL in 1 BLISTER PACK; Type 0: Not a Combination Product	12/17/2021	11/30/2023
5	NDC: 71220-082-40	1 in 1 BOX	01/01/2023	06/05/2025
5		100 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	03/01/2020	06/10/2025

Labeler - Innisfree Corporation (557822425)