STEBLANC WATER CC PACT 21 LIGHT BEIGE- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder 
Coson 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.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Titanium Dioxide 9.0055%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4.8%, Octocrylene 2%, Zinc Oxide 2%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
Water, Cyclopentasiloxane, C12-15 Alkyl benzoate, Cyclohexasiloxane, Glycerin, Niacinamide, PEG-30 Dipolyhydroxystearate, Quaternium-18 Bentonite, PEG-10 Dimethicone, Butylene Glycol, Sodium Chloride, Dimethicone, Iron Oxides (CI 77492), Ozokerite, Copernicia Cerifera (Carnauba) Wax, Iron Oxides (CI 77491), Chlorphenesin, Perfume, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Adenosine, Centella Asiatica Extract, Portulaca Oleracea Extract, Vitex Agnus Castus Extract, Chamomilla Recutita (Matricaria) Flower

PURPOSE

PURPOSE: UVA/UVB Protection

WARNINGS

WARNINGS:
1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.
2. Do not use on scarred skin, or if you have dermatitis or eczema
3. Keep the cap close on its product
4. Keep away from direct sunlight or heat.
5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATION & USAGE:
At the step of base make-up, tap the products gentlely on your face with the puff and let it absorb.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION:
At the stage of base make-up, apply it a suitable amount by using the provided applier.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

STEBLANC WATER CC PACT  21 LIGHT BEIGE
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62171-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.17 g  in 13 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.91 g  in 13 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.62 g  in 13 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.26 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.26 g  in 13 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
C12-15 Alkyl benzoate (UNII: A9EJ3J61HQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62171-050-0113 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2014
Labeler - Coson Co., Ltd. (689835593)
Registrant - Coson Co., Ltd. (689835593)
Establishment
NameAddressID/FEIBusiness Operations
Coson Co., Ltd.689835593manufacture(62171-050)

Revised: 9/2014
Document Id: fcf80cb4-7763-4ab4-b60f-3103f3e48534
Set id: b0a56202-c575-4e3e-a5b0-ebaae21acb52
Version: 1
Effective Time: 20140923
 
Coson Co., Ltd.