PROTECT THE TRUTH SPF 50 OLE HENRIKSEN- avobenzone,homosalate, octisalate,octocrylene,oxybenzone lotion

Protect The Truth SPF 50 by

Drug Labeling and Warnings

Protect The Truth SPF 50 by is a Otc medication manufactured, distributed, or labeled by Ole Henriksen of Denmark, Ole Henriksen of Denmark, HB Gordon Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients          Purpose

Avobenzone 3%            Prevention of Sunburn

Homosalate 10%           Prevention of Sunburn

Octisalate 5%                Prevention of Sunburn

Octocrylene 2.7%           Prevention of Sunburn

Oxybenzone 5%            Prevention of Sunburn

prevention of sunburn

Keep out of reach of children

provides high protection

helps protect against  sunburn

Stop use and ask a doctor if: rash or irritation develops or lasts.

apply smoothly and evenly to face and neck. repeat as necessary

children under 6 months of age: ask doctor

Water (Aqua/Eau), Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Thermus Thermophillus Ferment, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Vitis Vinifera (Grape) Fruit Cell Extract, Algae Extract, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Camellia Oleifera Leaf Extract, Pullulan, Isomalt, Lecithin, Glycerin, Dimethicone, Silica, Ceteareth-20, Sodium Phytate, Xanthan Gum, Citric Acid, Sodium Benzoate, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Fragrance (Parfum).

PRINCIPAL DISPLAY PANEL

OleHenriksen

all skin type/ Anti Aging

Protect the truth SPF 50+

broad spectrum UV Protection with Solar Active Complex

Sunscreen Lotion

1.7 fl.oz./ 50 ml

INGREDIENTS AND APPEARANCE

PROTECT THE TRUTH SPF 50  OLE HENRIKSEN
avobenzone,homosalate, octisalate,octocrylene,oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51770-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
PULLULAN (UNII: 8ZQ0AYU1TT)
ISOMALT (UNII: S870P55O2W)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51770-222-02	1 in 1 BOX
1	NDC: 51770-222-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2011

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(51770-222)