Label: MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 13733-014-01 - 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 November 22, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Sodium Hydroxide, Dimethicone, Polyacrylate-13, PEG-100 Stearate, Polyisobutene, Sorbitan Stearate, Panthenol, Aloe Barbadensis Leaf Juice, Sorbitan Isostearate, Polysorbate 20, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Water, Portulaca Oleracea Extract, Nelumbo Nucifera Flower Extract, Rosa Davurica Bud Extract, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Diospyros Kaki Leaf Extract, Pueraria Lobata Root Extract, Cinnamomum Cassia Bark Extract, Artemisia princeps Leaf Extract, Morus Alba Fruit Extract, BHT, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13733-014 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 mL in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.4 mL in 50 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2 mL in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM HYDROXIDE (UNII: 55X04QC32I) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-100 STEARATE (UNII: YD01N1999R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYSORBATE 20 (UNII: 7T1F30V5YH) MORUS ALBA ROOT (UNII: CST1G9BZGD) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CUCUMBER (UNII: YY7C30VXJT) WITCH HAZEL (UNII: 101I4J0U34) PURSLANE (UNII: M6S840WXG5) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C) DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L) DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) CHINESE CINNAMON (UNII: WS4CQ062KM) ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13733-014-01 50 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2011 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