Label: FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SPICE- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-2059-1, 67938-2059-2 - Packager: ELIZABETH ARDEN, 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 January 5, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- Reapply:
- at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
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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 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor.
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Inactive Ingredients
WATER/AQUA/EAU, CYCLO- PENTASILOXANE, ETHYLHEXYL ISONONANOATE, POLYMETHYL- SILSESQUIOXANE, DIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, NYLON-12, ISODODECANE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALCOHOL DENAT., MICA, C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER, BORON NITRIDE, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ALUMINUM DIMYRISTATE, BAMBUSA ARUNDINACEA STEM POWDER, CITRIC ACID, CYCLOHEXA- SILOXANE, DIMETHICONE/ PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIPROPYLENE GLYCOL DISODIUM EDTA, DISODIUM STEAROYL GLUTAMATE, HYDROXYETHYL- CELLULOSE, LAUROYL LYSINE, LECITHIN, MAGNESIUM SULFATE, PENTYLENE GLYCOL, POLYSORBATE 60, SACCHARIDE ISOMERATE, SILICA, SODIUM CITRATE, SORBITAN STEARATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYL- SILANE, ZINC GLYCYRRHETINATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (Cl 77491, Cl 77492, Cl 77499), TITANIUM DIOXIDE (Cl 77891).
- Other Information
- Questions or comments?
- Principal Display Panel - Box Label
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INGREDIENTS AND APPEARANCE
FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SPICE
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-2059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.725 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.346 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MICA (UNII: V8A1AW0880) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) NYLON-12 (UNII: 446U8J075B) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ALCOHOL (UNII: 3K9958V90M) BORON NITRIDE (UNII: 2U4T60A6YD) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM SULFATE (UNII: DE08037SAB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAUROYL LYSINE (UNII: 113171Q70B) EDETATE DISODIUM (UNII: 7FLD91C86K) CHLORPHENESIN (UNII: I670DAL4SZ) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ALUMINUM DIMYRISTATE (UNII: J2KA067N9O) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) BAMBUSA BAMBOS STEM (UNII: NRA4497HC5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIPROPYLENE GLYCOL (UNII: E107L85C40) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SACCHARIDE ISOMERATE (UNII: W8K377W98I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CITRATE (UNII: 1Q73Q2JULR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-2059-1 1 in 1 BOX 1 NDC:67938-2059-2 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/05/2015 Labeler - ELIZABETH ARDEN, INC (849222187) Establishment Name Address ID/FEI Business Operations KOLMAR 001535103 MANUFACTURE(67938-2059)
