Label: STEBLANC WATER CC PACT 23 NATURAL BEIGE- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 62171-060-01 - Packager: Coson Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 23, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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, Iron Oxides (CI 77492), Dimethicone, Iron Oxides (CI 77491), Ozokerite, Copernicia Cerifera (Carnauba) Wax, Chlorphenesin, Perfume, Triethoxycaprylylsilane, Aluminum Hydroxide, Iron Oxides (CI 77499),Adenosine, Centella Asiatica Extract, Portulaca Oleracea Extract, Vitex Agnus Castus Extract, Chamomilla Recutita (Matricaria) Flower - PURPOSE
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STEBLANC WATER CC PACT 23 NATURAL BEIGE
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62171-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.17 g in 13 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 0.91 g in 13 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.62 g in 13 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 0.26 g in 13 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.26 g in 13 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) C12-15 Alkyl benzoate (UNII: A9EJ3J61HQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62171-060-01 13 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2014 Labeler - Coson Co., Ltd. (689835593) Registrant - Coson Co., Ltd. (689835593) Establishment Name Address ID/FEI Business Operations Coson Co., Ltd. 689835593 manufacture(62171-060)
