Label: CERAMIDE LIFT AND FIRM EYE SUNSCREEN SPF 15- octinoxate and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0993-1, 67938-0993-2 - 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 April 16, 2013
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- DESCRIPTION
- INDICATIONS AND USAGE
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WARNINGS
Warnings:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
- OTC - ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Othe Ingredients: Water/Aqua/Eau, Dimethicone, Cetyl Ricinoleate, Octinoxate, Cetearyl Alcohol, Glycerin, Synthetic Beeswax, Butylene Glycol, Stearyl Heptanoate, Myristal Myristate, Isononyl Isononanoate, Oxybenzone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de Carnauba, PPG-2 Isoceteth-20 Acetate, Ceteth-20, Penoxyethanol, Cyclopentasiloxane, Myristyl Laurate, PEG-100 Stearate, Ascorbyl Glucoside, Beeswax/Cera Alba/Cire d'Abeille, BIS-PEG-12 Dimethicone, PEG-20, Sorbitan Tristearate, Steareth-100, Hibiscus Abelmoschuss Seed Extract, Propylene Glycol, VP/Eicosense Copolymer, BHT, Diazolidnyl Urea, Disodium EDTA, Hesperidin Methyl Chalcone, Sodium Hydroxide, Steareth-20, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Methylparaben, Sodium Lauroyl Lactylate, Xanthan Gum, Silica, Propylparaben, Glycine Soja (Soybean) Seed Extract, PVP, Ceramide 3, Chlorhexdine Digluconate, Phospholipids, Ceramide 6 II, Dipeptide-2, Phytosphingosine, Potassium Sorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Palmitoyl Tetrapeptide-7, Acetyl Octapeptide-3, Ceramide 1.
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CERAMIDE LIFT AND FIRM EYE SUNSCREEN SPF 15
octinoxate and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-0993 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.58896 g in 14.4 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.2016 g in 14.4 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL RICINOLEATE (UNII: 1P677500YD) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARYL HEPTANOATE (UNII: 2M4UGL1NCN) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CARNAUBA WAX (UNII: R12CBM0EIZ) PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419) CETETH-20 (UNII: I835H2IHHX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MYRISTYL LAURATE (UNII: 58U0NZN2BT) PEG-100 STEARATE (UNII: YD01N1999R) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) YELLOW WAX (UNII: 2ZA36H0S2V) SORBITAN TRISTEARATE (UNII: 6LUM696811) STEARETH-100 (UNII: 4OH5W9UM87) ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARETH-20 (UNII: L0Q8IK9E08) APPLE (UNII: B423VGH5S9) GREEN TEA LEAF (UNII: W2ZU1RY8B0) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) XANTHAN GUM (UNII: TTV12P4NEE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPYLPARABEN (UNII: Z8IX2SC1OH) SOYBEAN (UNII: L7HT8F1ZOD) CERAMIDE 3 (UNII: 4370DF050B) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) CERAMIDE 6 II (UNII: F1X8L2B00J) VALYLTRYPTOPHAN (UNII: 3G64B4AFQN) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CERAMIDE 1 (UNII: 5THT33P7X7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-0993-1 1 in 1 BOX 1 NDC:67938-0993-2 14.4 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/27/2010 Labeler - Elizabeth Arden, Inc (849222187)