Label: COMPLEXION BRIGHTENER SPF20- titanium dioxide and zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 41442-123-01, 41442-123-02 - Packager: Omorovicza Kozmetikai Kft.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 1, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- USES
- WARNING
- DIRECTIONS
-
INGREDIENTS
Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Titanium Dioxide, Cetearyl Ethylhexanoate, Cetearyl Olivate, Corundum (Pro Ruby Crystal), Sorbitan Olivate, Stearyl Heptanoate, Saccharomyces Ferment Extract, Alcohol Denat., Mica, Phenoxyethanol, Cetearyl Alcohol, Niacinamide, Polyhydroxystearic Acid, Isostearic Acid, Zinc PCA, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Nasturtium Officinale Flower/Leaf Extract, Malpighia Punicifolia (Acerola) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Pectin, Prunus Armeniaca (Apricot) Kernel Oil, Phospholipids, Tocopherol, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Lactic Acid
- PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
COMPLEXION BRIGHTENER SPF20
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41442-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide 0.84 mL in 30 mL Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide 2.1 mL in 30 mL Inactive Ingredients Ingredient Name Strength Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85) Glycerin (UNII: PDC6A3C0OX) Squalane (UNII: GW89575KF9) Cetearyl Ethylhexanoate (UNII: 9M64UO4C25) Cetearyl Olivate (UNII: 58B69Q84JO) Sorbitan Olivate (UNII: MDL271E3GR) Stearyl Heptanoate (UNII: 2M4UGL1NCN) Alcohol (UNII: 3K9958V90M) Mica (UNII: V8A1AW0880) Phenoxyethanol (UNII: HIE492ZZ3T) Cetostearyl Alcohol (UNII: 2DMT128M1S) Niacinamide (UNII: 25X51I8RD4) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Isostearic Acid (UNII: X33R8U0062) Zinc Pidolate (UNII: C32PQ86DH4) Geraniol (UNII: L837108USY) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) LINALOOL, (+)- (UNII: F4VNO44C09) Rorippa Nasturtium-Aquaticum Flowering Top (UNII: W1N2U8I64G) Acerola (UNII: XDD2WEC9L5) Apple (UNII: B423VGH5S9) Pectin (UNII: 89NA02M4RX) Apricot Seed Oil (UNII: 54JB35T06A) Alpha-Tocopherol (UNII: H4N855PNZ1) Edetate Disodium (UNII: 7FLD91C86K) Xanthan Gum (UNII: TTV12P4NEE) Ethylhexylglycerin (UNII: 147D247K3P) Lactic Acid (UNII: 33X04XA5AT) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41442-123-01 1 in 1 BOX 1 30 mL in 1 BOTTLE, GLASS 2 NDC:41442-123-02 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2011 Labeler - Omorovicza Kozmetikai Kft. (525432105) Establishment Name Address ID/FEI Business Operations Omorovicza Kozmetikai Kft. 525432105 LABEL, MANUFACTURE
