Label: TIMELESS AGE DEFYING SPF 20 MERLE NORMAN- octinoxate, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57627-115-01, 57627-115-02 - Packager: Merle Norman
- 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 January 23, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
For sunscreen use:
· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating
· Reapply 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 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 -
INACTIVE INGREDIENT
Inactive ingredients: Water (Aqua), Titanium Dioxide, Butylene Glycol, Octldodecyl Neopentanoate, Cyclopentasoloxane, Isodecyl Neopentanoate, Iron Oxides, Stearic Acid, Phenyl Trimethicone, Propylene Glycol Stearate SE, Squalane, Triethanolamine, Dipalmitoyl Hydroxyproline, Trilaurin, Ceramide 3, Hyaluronic Acid, Glycine Soja, ( Soybean) Seed Extract, Atelocollagen, Sodium Hyaluronate, Palmitoyl Oligopeptide, Ascorbyl Palmitate, Tocopheryl Acetate, Propylene Glycol Dipelargonate, Ethylene/ Acrylic Acid Copolymer, Panthenol, Allantoin, Lecithin, Glyceryl Polymethacrylate, Dimethionol, Cetyl Phosphate, Tricaprylin, Mica ( Cl 77019), Stearyl Alcohol, PEG-8, Cellulose gum, PEG-12 Dimethicone, Silica, Polyquaternium-24, Sodium Chondroitin Sulfate, Magnesium Aluminum Silicate, Carbomer, Polysorbate 20, Tetrasodium EDTA, Disodium EDTA, Diazolidinyl Urea, BHT, Ethylene Dodecanedioate Phenoxyethanol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TIMELESS AGE DEFYING SPF 20 MERLE NORMAN
octinoxate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.25 g in 30 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE .6 g in 30 mL Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) FERROUS OXIDE (UNII: G7036X8B5H) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STEARIC ACID (UNII: 4ELV7Z65AP) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SQUALANE (UNII: GW89575KF9) TROLAMINE (UNII: 9O3K93S3TK) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TRILAURIN (UNII: 7FP2Z3RVUV) CERAMIDE 3 (UNII: 4370DF050B) HYALURONIC ACID (UNII: S270N0TRQY) SOYBEAN (UNII: L7HT8F1ZOD) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) ASCORBYL PALMITATE (UNII: QN83US2B0N) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) CETYL PHOSPHATE (UNII: VT07D6X67O) TRICAPRYLIN (UNII: 6P92858988) MICA (UNII: V8A1AW0880) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) POLYSORBATE 20 (UNII: 7T1F30V5YH) EDETATE SODIUM (UNII: MP1J8420LU) EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-115-02 1 in 1 BOX 05/05/2011 1 NDC:57627-115-01 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 final part352 05/05/2011 Labeler - Merle Norman (008479388) Registrant - Merle Norman (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman 008479388 manufacture(57627-115)