TOTAL TRUTH EYE CREME SPF 15 OLE HENRIKSEN- avobenzone, octinoxate, octisalate cream

Total Truth Eye Creme SPF 15 by

Drug Labeling and Warnings

Total Truth Eye Creme SPF 15 by is a Otc medication manufactured, distributed, or labeled by Ole Henriksen of Denmark, HB Gordon Manufacturing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

OleHenriksen

total truth

eye creme SPF 15

Net Wt. 0.5oz./ 15g

INGREDIENTS AND APPEARANCE

TOTAL TRUTH EYE CREME SPF 15  OLE HENRIKSEN
avobenzone, octinoxate, octisalate cream

Product 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)