MISSHA SKIN FIT STICK FOUNDATION SPF50 NO.21- zinc oxide, titanium dioxide, octisalate, octinoxate, octocrylene stick
Able C&C Co., Ltd.

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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MISSHA Skin Fit Stick Foundation SPF50 No.21

ACTIVE INGREDIENTS

Titanium Dioxide 21.73%
Octinoxate 7.00%
Zinc Oxide 6.72%
Octisalate 4.50%
Octocrylene 3.00%

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

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to Remove.

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 againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10a.m.-2p.m.
wear long-sleeved shirts, pants, hats and sunglasses

Other Information

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

Keep Out of Reach of Children

if swalled, get medical help or contact Poison Control Center right away.

Inactive Ingredient

Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Dimethicone, Microcrystalline Wax, Octyldodecanol, Synthetic Wax, Mica (CI 77019), Copernicia Cerifera (Carnauba) Wax, Quaternium-18 Bentonite, CI 77492, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ethylene/Propylene Copolymer, Sorbitan Sesquioleate, Glycerin, Dipropylene Glycol, Triethoxycaprylylsilane, Sorbitan Isostearate, Dimethicone Crosspolymer, Water, Aluminum Hydroxide, Stearic Acid, CI 77491, Hydrogen Dimethicone, Caprylyl Glycol, Polyhydroxystearic Acid, Ethylhexylglycerin, Fragrance, Silica, Hydrogenated Lecithin, Polyglyceryl-10 Oleate, CI 77499, Lecithin, Isostearic Acid, Isopropyl Palmitate, Oil Soluble Licorice(Glycyrrhiza) Extract, 1,2-Hexanediol, Adenosine, Polyglyceryl-3 Polyricinoleate, Olea Europaea (Olive) Fruit Oil, Rosa Canina Fruit Oil, Astrocaryum Murumuru Seed Butter, Tocopherol

Questions of comments?

Visit www.misshaus.com or call 1-888-985-9887(Ext 104)

MISSHA Skin Fit Stick Foundation SPF50 No.21

MISSHA SKIN FIT STICK FOUNDATION SPF50 NO.21
zinc oxide, titanium dioxide, octisalate, octinoxate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13733-345
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.9408 g in 14 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.63 g in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.04185 g in 14 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.42 g in 14 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.98 g in 14 g

Ingredient Name	Strength
Inactive Ingredients
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENTOQUATAM (UNII: 7F465U79Q1)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
1,1'-OXYBIS(2-PROPANOL) (UNII: D5SV08985Z)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
16-METHYLHEPTADECANOIC ACID (UNII: LZM5XA0ILL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ADENOSINE (UNII: K72T3FS567)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TOCOPHEROL (UNII: R0ZB2556P8)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OLIVE OIL (UNII: 6UYK2W1W1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13733-345-01	14 g in 1 CARTON; Type 0: Not a Combination Product	11/16/2017	12/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/16/2017	12/09/2018

Labeler - Able C&C Co., Ltd. (689540284)

Registrant - Able C&C Co., Ltd. (689540284)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmecca Korea Co., Ltd.		688830827	manufacture(13733-345)

Revised: 12/2018

Document Id: 7cee5330-4f52-3b14-e053-2a91aa0acfba

Set id: 575f2b75-90ed-5d17-e053-2a91aa0a44b9

Version: 3

Effective Time: 20181213

Able C&C Co., Ltd.