TOTAL TRUTH EYE CREME SPF 15 OLE HENRIKSEN- avobenzone, octinoxate, octisalate cream 
Ole Henriksen of Denmark

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.

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Total Truth Eye Cream SPF 15

Active Ingredients            Purpose

Avobenzone 2.0%            prevention of sunburn

Octinoxate 4.0%                prevention of sunburn

Octisalate 4.0%                prevention of sunburn

prevention of sunburn

keep out of reach of children

provides moderate protection


helps against sunburn

stop use and ask a doctor if rash or irritation develops and lasts

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.

image of back label

image of front label


OleHenriksen

total truth

eye creme SPF 15

Net Wt. 0.5oz./ 15g

TOTAL TRUTH EYE CREME SPF 15  OLE HENRIKSEN
avobenzone, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51770-154
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51770-154-021 in 1 BOX
1NDC:51770-154-0115 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/14/2011
Labeler - Ole Henriksen of Denmark (133369058)
Registrant - Ole Henriksen of Denmark (133369058)
Establishment
NameAddressID/FEIBusiness Operations
HB Gordon Manufacturing Inc.008328619manufacture(51770-154)

Revised: 7/2013
Document Id: ec107a68-23c3-4d5d-b348-5d7218f16340
Set id: 59987838-db3c-4065-a704-d08ff03f4dd2
Version: 7
Effective Time: 20130708
 
Ole Henriksen of Denmark