FRIDA KAHLO EDITION TENSION PACT INTENSE MOISTURE SPF37 NO29- titanium dioxide, octinoxate, zinc oxide, cream
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 The Original Tension Pact Intense Moisture SPF37 No 29 - Frida Kahlo Edition

ACTIVE INGREDIENTS

Titanium Dioxide 10.2%

Octinoxate 5%

Zinc Oxide 2.9%

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

Inactive Ingredient

Water, Phenyl Trimethicone, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Cyclopentasiloxane, Ferric Oxide Yellow, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Niacinamide, Pentylene Glycol, Cyclohexasiloxane, Dextrin Palmitate/Ethylhexanoate, Disteardimonium Hectorite, PEG-10 Dimethicone

Questions of comments?

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

MISSHA THE ORIGINAL TENSION PACT INTENSE MOISTURE SPF37 NO 29 - FRIDA KAHLO EDITION

FK_Edition_TensionPactIntenseMoistureNo29

FRIDA KAHLO EDITION TENSION PACT INTENSE MOISTURE SPF37 NO29
titanium dioxide, octinoxate, zinc oxide, cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13733-299
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.2 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.9 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
NIACINAMIDE (UNII: 25X51I8RD4)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13733-299-01	14 g in 1 CARTON; Type 0: Not a Combination Product	02/01/2017	10/27/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017	10/27/2018

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc		689049693	manufacture(13733-299)

Revised: 10/2018

Document Id: 792ab2da-750a-e0d1-e053-2991aa0a6f65

Set id: 4fe98406-99ad-049b-e054-00144ff88e88

Version: 2

Effective Time: 20181026

Able C&C Co., Ltd.