Label: IMAN TIME CONTROL OIL FREE MOISTURE COMPLEX SPF 15- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50950-002-01 - Packager: Sheencolor Biotech 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 5, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
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INACTIVE INGREDIENT
Inactive Ingredients
Water, Cetyl Palmitate, Glyceryl Stearate, Myristate Alcohol, Dimethicone, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Caprylic/Capric Triglyceride, Pseudoalteromonas Ferment Extract, Hydrolyzed Wheat Protein, Hydrolyzed Soy Protein, Hydrolyzed Silk, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sodium Glycotate, Lactic Acid, Glycolic Acid, Malic Acid, Citric Acid, Sodium Citrate, Sodium Malate, Prunus Armeniaca Fruit Extract, Ginkgo Biloba Leaf Extract, Salix Nigra (Willow) Bark Extract, Sodium C8-16 Isoalkylsuccinyl Lactoglobulin Sulfonate, Aloe Barbadensis Leaf Extract, Alcohol Denat, Lecithin, Glycerin, PEG-100 Stearate, Triethanolamine, Phenoxyethanol, Carbomer, Methylparaben, Propylparaben, Isobutylparaben, Butylparaben, Ethylparaben, Disodium EDTA, Fragrance (Parfum)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IMAN TIME CONTROL OIL FREE MOISTURE COMPLEX SPF 15
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50950-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 75.5795 g in 100 g ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.0066 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 0.71 g in 100 g GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2.5 g in 100 g CETYL PALMITATE (UNII: 5ZA2S6B08X) 2.50 g in 100 g WILLOW BARK (UNII: S883J9JDYX) 0.08 g in 100 g TEA LEAF OIL (UNII: VC855RRT77) 0.02 g in 100 g POLYOXYL 100 STEARATE (UNII: YD01N1999R) 0.8 g in 100 g ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g in 100 g APRICOT JUICE (UNII: YX3B7ZG375) 0.02 g in 100 g HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.10 g in 100 g GINKGO (UNII: 19FUJ2C58T) 0.02 g in 100 g ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.0003 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g in 100 g MYRISTYL ALCOHOL (UNII: V42034O9PU) 2.0 g in 100 g ALCOHOL (UNII: 3K9958V90M) 0.1 g in 100 g TROLAMINE (UNII: 9O3K93S3TK) 0.512 g in 100 g CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.5 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.798 g in 100 g METHYLPARABEN (UNII: A2I8C7HI9T) 0.17 g in 100 g PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.022 g in 100 g ISOBUTYLPARABEN (UNII: 0QQJ25X58G) 0.022 g in 100 g BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.044 g in 100 g ETHYLPARABEN (UNII: 14255EXE39) 0.044 g in 100 g EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g in 100 g LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.1 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) 1.5 g in 100 g VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1 g in 100 g MALIC ACID (UNII: 817L1N4CKP) 0.0003 g in 100 g GLYCOLIC ACID (UNII: 0WT12SX38S) 0.0003 g in 100 g LACTIC ACID (UNII: 33X04XA5AT) 0.0027 g in 100 g SODIUM LACTATE (UNII: TU7HW0W0QT) 0.02 g in 100 g SODIUM GLYCOLATE (UNII: B75E535IMI) 0.0066 g in 100 g SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 0.0066 g in 100 g MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.1 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50950-002-01 89 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/10/2010 Labeler - Sheencolor Biotech Co., Ltd. (545285306) Registrant - Sheencolor Biotech Co., Ltd. (545285306) Establishment Name Address ID/FEI Business Operations Sheencolor Biotech Co., Ltd. 545285306 manufacture