innisfree Gentle Care for Sensitive Skin Sunscreen

innisfree Gentle Care for Sensitive Skin Sunscreen by

Drug Labeling and Warnings

innisfree Gentle Care for Sensitive Skin Sunscreen by is a Otc medication manufactured, distributed, or labeled by Innisfree Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INNISFREE GENTLE CARE FOR SENSITIVE SKIN SUNSCREEN- titanium dioxide lotion lotion 
Innisfree Corporation

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innisfree Gentle Care for Sensitive Skin Sunscreen

Drug Facts

ACTIVE INGREDIENTS

Titanium Dioxide 4.46%

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 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 swallowed, call a poison control centre or get medical help 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.

OTHER INFORMATION

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

INACTIVE INGREDIENTS

WATER / AQUA / EAU, PROPANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, POLYHYDROXYSTEARIC ACID, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ALUMINA, STEARIC ACID, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, POLYACRYLATE CROSSPOLYMER-6, ETHYLHEXYLGLYCERIN, T-BUTYL ALCOHOL, TOCOPHEROL

Questions?

support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL

Innisfree

Gentle Care

for Sensitive Skin

Sunscreen

Braod Spectrum SPF 29

40 mL / 1.35 Fl. Oz.

INNISFREE GENTLE CARE FOR SENSITIVE SKIN SUNSCREEN 
titanium dioxide lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.784 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
PROPANEDIOL (UNII: 5965N8W85T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-084-09	1 in 1 CARTON	06/15/2020	07/13/2023
1		40 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	06/15/2020	07/13/2023

Labeler - Innisfree Corporation (557822425)

Revised: 11/2023

Document Id: 0b52ec38-ed7a-5edd-e063-6294a90a0278

34390-5

Set id: a51530af-3f54-833c-e053-2a95a90a1629

Version: 3

Effective Time: 20231129