Label: SUNKISS- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 41442-133-01 - Packager: Omorovicza Kozmetikai Kft
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated May 6, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- USES
- WARNING
- DIRECTIONS
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INGREDIENTS
Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Titanium Dioxide, Corundum (Pro Ruby Crystal), Cetearyl Ethylhexanoate, Cetearyl Olivate, Sorbitan Olivate, Stearyl Heptanoate, Cetearyl Alcohol, Saccharomyces Ferment Extract, Phenoxyethanol, Polyhydroxystearic Acid, Isostearic Acid, Mica, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Prunus Armeniaca (Apricot) Kernel Oil, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Malpighia Punicifolia (Acerola) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Pectin, Phospholipids, Tocopherol, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Lactic Acid, Galactoarabinan, Isopropyl Titanium Triisostearate, CI 77492/ CI 77491/ CI 77499 (Iron Oxides).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50ml Bottle Carton
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INGREDIENTS AND APPEARANCE
SUNKISS SPF15
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41442-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide 0.675 mL in 50 mL zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide 3 mL in 50 mL Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85) glycerin (UNII: PDC6A3C0OX) squalane (UNII: GW89575KF9) aluminum oxide (UNII: LMI26O6933) sorbitan olivate (UNII: MDL271E3GR) STEARYL ETHYLHEXANOATE (UNII: X8707A2274) cetostearyl alcohol (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) isostearic acid (UNII: X33R8U0062) mica (UNII: V8A1AW0880) geraniol (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) linalool, dl- (UNII: D81QY6I88E) APRICOT KERNEL OIL (UNII: 54JB35T06A) acerola (UNII: XDD2WEC9L5) apple (UNII: B423VGH5S9) pectin (UNII: 89NA02M4RX) alpha-tocopherol (UNII: H4N855PNZ1) Edetate Disodium (UNII: 7FLD91C86K) xanthan gum (UNII: TTV12P4NEE) ethylhexylglycerin (UNII: 147D247K3P) lactic acid (UNII: 33X04XA5AT) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41442-133-01 1 in 1 BOX 1 50 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/06/2011 Labeler - Omorovicza Kozmetikai Kft (525432105) Establishment Name Address ID/FEI Business Operations Omorovicza Kozmetikai Kft 525432105 LABEL, MANUFACTURE