Label: VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15- octinoxate, avobenzone, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-1169-1, 67938-1169-2 - 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 May 1, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DESCRIPTION
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INDICATIONS AND USAGE
To Use: Smooth onto cleansed face and throat.
Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses.
Children under 6 months ask a doctor.
- WARNINGS
- OTC - ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water/Aqua/Eau, Butylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Pentylene Glycol, Butyl Stearate, Tridecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extrat, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hyrdolyzed Soy Protein, Lecithin, Phospholipids, Polyphophorylcholine Glycol Acrylate, Ammonium Acryloyldimethylaurate/VP Coplymer, PEG-100 Stearate, PEG-8 Laurate, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Xanthan Gum, Nylon-12, BHT, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Benzyl Salicylate, Butylphenyl Methylpropional, Citonellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limnene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Titanium Dioxide (CI 77891).
- DOSAGE AND ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15
octinoxate, avobenzone, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-1169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 g in 50 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.5 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DIMETHICONE (UNII: 92RU3N3Y1O) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYL STEARATE (UNII: 6Y0AI5605C) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) CETYL RICINOLEATE (UNII: 1P677500YD) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) NARCISSUS TAZETTA BULB (UNII: K17762966S) TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) TREHALOSE (UNII: B8WCK70T7I) UREA (UNII: 8W8T17847W) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) PEG-100 STEARATE (UNII: YD01N1999R) PEG-8 LAURATE (UNII: 762O8IWA10) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ISODODECANE (UNII: A8289P68Y2) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) XANTHAN GUM (UNII: TTV12P4NEE) NYLON-12 (UNII: 446U8J075B) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) MICA (UNII: V8A1AW0880) STANNIC OXIDE (UNII: KM7N50LOS6) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLPARABEN (UNII: 3QPI1U3FV8) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBIC ACID (UNII: X045WJ989B) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-1169-1 1 in 1 CARTON 1 NDC:67938-1169-2 50 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/15/2011 Labeler - Elizabeth Arden, Inc (849222187)
