FRIDA KAHLO EDITION TENSION PACT INTENSE MOISTURE SPF37 NO21- titanium dioxide, octinoxate, zinc oxide, cream 
FRIDA KAHLO EDITION TENSION PACT INTENSE MOISTURE SPF37 NO23- 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- Frida Kahlo Edition

ACTIVE INGREDIENTS

Titanium Dioxide 9.7%

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, Cyclopentasiloxane, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Butylene Glycol, Niacinamide, Pentylene Glycol, Dextrin Palmitate/Ethylhexanoate, Disteardimonium Hectorite, Synthetic Fluorphlogopite, PEG-10 Dimethicone, Magnesium Sulfate

Questions of comments?

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

MISSHA THE ORIGINAL TENSION PACT INTENSE MOISTURE SPF37 NO 21 - FRIDA KAHLO EDITION

FK_TensionPactIntenseMoisture

MISSHA THE ORIGINAL TENSION PACT INTENSE MOISTURE SPF37 NO 23 - FRIDA KAHLO EDITION

FK_TensionPactIntenseMoistureNo23

FRIDA KAHLO EDITION TENSION PACT INTENSE MOISTURE SPF37 NO21 
titanium dioxide, octinoxate, zinc oxide, cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-296
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.7 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.9 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-296-0114 g in 1 CARTON; Type 0: Not a Combination Product02/01/201710/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201710/27/2018
FRIDA KAHLO EDITION TENSION PACT INTENSE MOISTURE SPF37 NO23 
titanium dioxide, octinoxate, zinc oxide, cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-297
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.7 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.9 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-297-0114 g in 1 CARTON; Type 0: Not a Combination Product02/01/201710/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201710/27/2018
Labeler - Able C&C Co., Ltd. (689540284)
Registrant - Able C&C Co., Ltd. (689540284)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(13733-296, 13733-297)

Revised: 10/2018
Document Id: 792a8353-becb-5231-e053-2a91aa0a419d
Set id: 4fe8d47a-406a-65cf-e054-00144ff88e88
Version: 2
Effective Time: 20181026
 
Able C&C Co., Ltd.