Label: TAKE COVER ANTI-AGING FOUNDATION LIGHT- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51389-114-03 - Packager: LAURA GELLER MAKE UP INC.
- 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 June 8, 2012
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- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
- Apply generously 15 minutes before sun exposure.
- Reapply:
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- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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:
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- limit time in the sun, especially from 10 a.m.- 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months of age: Ask a doctor.
- Apply generously 15 minutes before sun exposure.
- Other Information
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Inactive Ingredients
Cyclopentasiloxane,Water(Aqua), Trimethylolpropane, Triisostearate, Dimethicone, Isododecane, PEG/PPG-18/18 Dimethicone, Butylene Glycol, Hexyl Laurate, Disteardimonium Hectorite, C12-C15 Alkyl Benzoate, Polyglyceryl-4 Isostearate, Dimethiconol, Dipalmitoyl Hydroxyproline, Dimethicone/Divinyldimethicone/Silses-quioxane Crosspolymer, Polysilicone-11, Phenoxyethanol, Sodium Chloride, Magnesium Aluminium Silicate, PEG-10 Dimethicone, Coco-Caprylate/Caprate, Lecithin, Theobroma Grandiflorum Seed Butter, Cetyl PEG/PPG-10 Dimethicone, Tribehenin, Stearic Acid, Propylene Carbonate, Alumina, Methylparaben, Tocopheryl Acetate, Ceramide 2, PEG-10 Rapeseed Sterol, Triethoxycaprylysilane, Butylparaben, Ethylparaben, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben, Decyl Glucoside, Isobutylparaben, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Caprylyl Glycol, Hexylene Glycol,Laureth-12, Plamitoyl Oligopeptide May Contain:Titanium Dioxide(CI 77891),Mica(CI 77019), Iron Oxides(CI 77492,CI 77491, CI 77499)
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INGREDIENTS AND APPEARANCE
TAKE COVER ANTI-AGING FOUNDATION LIGHT
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51389-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.95 g in 100 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) TRIMETHYLOLPROPANE (UNII: 090GDF4HBD) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONOL (250000 MW) (UNII: RKI3S914RT) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) TRIBEHENIN (UNII: 8OC9U7TQZ0) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALUMINUM OXIDE (UNII: LMI26O6933) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CERAMIDE 2 (UNII: C04977SRJ5) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LAURETH-12 (UNII: OAH19558U1) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51389-114-03 29.57 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/08/2012 Labeler - LAURA GELLER MAKE UP INC. (199474524)