Label: TOTAL TRUTH EYE CREME SPF 15 OLE HENRIKSEN- avobenzone, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51770-154-01, 51770-154-02 - Packager: Ole Henriksen of Denmark
- 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 July 8, 2013
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 2.0% prevention of sunburn
Octinoxate 4.0% prevention of sunburn
Octisalate 4.0% prevention of sunburn
apply smoothly and evenly to face and neck
repeat as necessary
children under 6 month of age , ask doctor.
Water (Aqua, Eau), Glycerin, C12-15 Alkyl Benzoate, Dimethicone,Helianthus Annuus (Sunflower) Seed Oil, Stearic Acid, Stearyl Alcohol,Glyceryl Stearate SE, Vitis Vinifera(Grape) Seed Oil, Glycery Stearate,PEG-100 Stearate, Cetearyl Alcohol,Limnanthes Alba (Meadowfoam) Seed Oil, Ceteareth-20, Phenoxyethanol,Algae Extract, Pullulan, Palmitoyl Tripeptide-5, Sodium Hyaluronate,Tocopheryl Acetate, Retinyl Palmitate, Allantoin, Volubilis (Mountain Peanut)Seed Oil, Schinus Terebinthifolius Seed Extract, Magnesium Ascorbyl Phosphate, Triethanolamine, Carbomer,Potassium Sorbate, Alcohol, Lecithin.
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INGREDIENTS AND APPEARANCE
TOTAL TRUTH EYE CREME SPF 15 OLE HENRIKSEN
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51770-154 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER OIL (UNII: 3W1JG795YI) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENOXYETHANOL (UNII: HIE492ZZ3T) PULLULAN (UNII: 8ZQ0AYU1TT) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) HYALURONATE SODIUM (UNII: YSE9PPT4TH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALLANTOIN (UNII: 344S277G0Z) BRAZILIAN PEPPER (UNII: SUG822G7CD) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) TROLAMINE (UNII: 9O3K93S3TK) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51770-154-02 1 in 1 BOX 1 NDC:51770-154-01 15 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/14/2011 Labeler - Ole Henriksen of Denmark (133369058) Registrant - Ole Henriksen of Denmark (133369058) Establishment Name Address ID/FEI Business Operations HB Gordon Manufacturing Inc. 008328619 manufacture(51770-154)
