Label: THE CURE OIL-FREE- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63730-222-01 - Packager: Natura Bisse International SA
- 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 April 30, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before skin exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sun-glasses
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Glycerin, Diisopropyl Sebacate, Ethylene/Acrylic Acid Copolymer, Caprylic/Capric Triglyceride, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Glyceryl Linoleate, Arginine, Hydrolyzed Collagen, Bisabolol, Lactic Acid, Sodium Lactate, Serine, Sorbitol, Urea, Glyceryl Linolenate, Niacinamide, Yeast Extract, Aesculus
Hippocastanum (Horse Chestnut) Seed Extract, Sodium Hyaluronate, Ammonium Glycyrrhizate, Zinc Gluconate, Panthenol, Allantoin, Caffeine, Biotin, Palmitoyl Tripeptide-38, Lepidium Sativum Sprout Extract, Aluminum Hydroxide, Sodium Chloride, Stearic Acid, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Silica Silylate, Stearalkonium Hectorite, Dimethiconol, Disodium EDTA, Palmitamidopropyltrimonium Chloride, Dimethicone Crosspolymer, Propylene Carbonate, Ethylhexylglycerin,
Pentylene Glycol, Hydroxypropyl Cyclodextrin, Sodium Citrate, Citric Acid, Lecithin, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Fragrance (Parfum), Iron Oxides (CI 77492, CI 77491, CI 77499). - OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THE CURE OIL-FREE
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63730-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 50 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SALIX ALBA BARK (UNII: 205MXS71H7) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL LINOLEATE (UNII: 4763AXI84L) ARGININE (UNII: 94ZLA3W45F) GELATIN (UNII: 2G86QN327L) LEVOMENOL (UNII: 24WE03BX2T) LACTIC ACID (UNII: 33X04XA5AT) SODIUM LACTATE (UNII: TU7HW0W0QT) SERINE (UNII: 452VLY9402) SORBITOL (UNII: 506T60A25R) UREA (UNII: 8W8T17847W) GLYCERYL LINOLENATE (UNII: SGB6X4G86K) NIACINAMIDE (UNII: 25X51I8RD4) YEAST (UNII: 3NY3SM6B8U) AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) HYALURONATE SODIUM (UNII: YSE9PPT4TH) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) CAFFEINE (UNII: 3G6A5W338E) BIOTIN (UNII: 6SO6U10H04) PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O) LEPIDIUM SATIVUM SEED (UNII: WZM06UL78H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CHLORIDE (UNII: 451W47IQ8X) STEARIC ACID (UNII: 4ELV7Z65AP) DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) EDETATE DISODIUM (UNII: 7FLD91C86K) PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) BROWN IRON OXIDE (UNII: 1N032N7MFO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63730-222-01 50 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/21/2014 Labeler - Natura Bisse International SA (464431576) Establishment Name Address ID/FEI Business Operations Natura Bisse International SA 464431576 manufacture(63730-222)