Label: MISSHA SIGNATURE DRAMATIC WHITENING PACT NO.2 SPF50 PLUS PA PLUS PLUS PLUS- titanium dioxide, octinoxate, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 13733-015-01 - Packager: ABLE C&C CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 October 25, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
Mica, Talc, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Nylon-12, Boron Nitride, Dimethicone, Methicone, Methyl Methacrylate Crosspolymer, Lauroyl Lysine, Phenyl Trimethicone, Pentaerythrityl Tetraisostearate, Iron Oxides, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Ethylhexylglycerin, Glyceryl Caprylate, Aluminum Hydroxide, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxypropyl Bispalmitamide MEA, Ultramarines (CI 77007), Water, Fragrance(Parfum), Zea Mays (Corn) Starch, Hydroxyapatite, Saccharomyces Lysate Extract, Phenoxyethanol, Butylene Glycol, Sodium Hyaluronate, Betula Platyphylla Japonica Juice, Nelumbo Nucifera Flower Water, HDI/Trimethylol Hexyllactone Crosspolymer, Propylene Glycol, Acacia Senegal Gum, Tin Oxide, Dipropylene Glycol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Palmitoyl Proline, Lavandula Angustifolia (Lavender) Extract, Thymus Vulgaris (Thyme) Extract, Origanum Vulgare Leaf/Flower/Stem Extract, Hydrolyzed Rhizobian Gum, Camellia Sinensis Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Melissa Officinalis Leaf Extract, Rosa Canina Fruit Extract, Aspalathus Linearis Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Nymphaea Alba Flower Extract, Hibiscus Sabdariffa Flower Extract, Euterpe Oleracea Fruit Extract, Sigesbeckia Orientalis Extract, Alchemilla Vulgaris Leaf Extract, Rabdosia Rubescens Extract, Hydrolyzed Myrtus Communis Leaf Extract, Hydrogenated Lecithin, Lilium Candidum Flower Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Sophora Angustifolia Root Extract, Saururus Chinensis Leaf/Root Extract, Poncirus Trifoliata Fruit Extract, Caprylyl Glycol, Acanthopanax Senticosus (Eleuthero) Root Extract, Diospyros Kaki Leaf Extract, Viscum Album (Mistletoe) Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Angelica Gigas Root Extract, Adenophora Stricta Root Extract, Zizyphus Jujuba Fruit Extract, Codonopsis Lanceolata Root Extract, Eucommia Ulmoides Extract, Polygonum Odoratum Extract, Sorbus Commixta Extract, Portulaca Oleracea Extract, Oenanthe Javanica Extract, Morus Bombycis Leaf Extract, Cornus Officinalis Fruit Extract, Cuscuta Japonica Seed Extract, Cirsium (Thistle) Flower/Leaf/Stem Extract, Schizandra Chinensis Fruit Extract, Leonurus Sibiricus Flower/Leaf/Stem Extract, Crataegus Cuneata Fruit Extract, Xanthium Strumarium Fruit Extract, Pueraria Thunbergiana Root Extract, Polygonum Multiflorum Root Extract, Eclipta Prostrata Extract, Astragalus Membranaceus Root Extract, Rubus Coreanus Fruit Extract, Saururus Chinensis Extract, Taraxacum Platycarpum Extract, Hydrolyzed Codonopsis Pilosula Root Extract, Aralia Elata Branch/Leaf Extract, Kalopanax Pictus Extract, Lactuca Indica Extract, Cinnamomum Cassia Bark Extract, Glycerin, Caprylhydroxamic Acid - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MISSHA SIGNATURE DRAMATIC WHITENING PACT NO.2 SPF50 PLUS PA PLUS PLUS PLUS
titanium dioxide, octinoxate, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13733-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.84 g in 11 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.66 g in 11 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.32 g in 11 g Inactive Ingredients Ingredient Name Strength Dimethicone (UNII: 92RU3N3Y1O) Glyceryl Caprylate (UNII: TM2TZD4G4A) Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13733-015-01 11 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2012 Labeler - ABLE C&C CO., LTD. (689540284) Registrant - ABLE C&C CO., LTD. (689540284) Establishment Name Address ID/FEI Business Operations ABLE C&C CO., LTD. 689540284 manufacture(13733-015)