TRUTH REVEALED SUPER CREME SPF 15 OLE HENRIKSEN- octinoxate, avobenzone, oxybenzone, octocrylene cream

Truth Revealed super creme SPF 15 by

Drug Labeling and Warnings

Truth Revealed super creme SPF 15 by is a Otc medication manufactured, distributed, or labeled by Ole Henriksen, HB GORDON MANUFACTURING INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                Purpose

Octinoxate  7.5%               Sunscreen
Avobenzone 2.0%              Sunscreen
Oxybenzone 2.0%              Sunscreen
Octocrylene 1.9%               Sunscreen

Uses:

Helps prevent sunburn.

Higher SPF gives more sunburn protection.

Keep out of reach of children

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

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

If swallowed, get immediate medical help or contact a poison control center right away.

Directions

Massage into skin in upward motion, outward circular motions

For children under 6 months, ask a doctor.

Inactive Ingredients

Water (Aqua,Eau), cocoglycerides, Glycerin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Palmitoyl Tripeptide-5, Algae Extract, Pullulan, Chondrus Chrispus (Carrageenan), Plukenetia Volubilis Seed Oil, Schinus Terebinthifolius Seed Extract, Tetrahexyldecyl Ascorbate, calcium Ascorbate, Sodium Hyaluronate, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Extract, Corylus Avellana (Hazelnut) extract, Avena Sativa (Oat) Meal Extract. Vaccinum Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharinum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Bisabolol, Allantoin, Tocopheryl Acetate, Carbomer, Ceteareth-20, Aminomethyl Propanol, sodium Phytate, Citric Acid, Polyacrylate-13/polyisobutene/polysorbate 20, Phenoxy ethanol, Ethylhexylglycerin, Potassium Sorbate, Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL

Ole Henriksen

All skin types/anti-aging

Truth Revealed Super Creme with SPF 15

Net. Wt. 1.7 oz/ 50g

INGREDIENTS AND APPEARANCE

TRUTH REVEALED SUPER CREME SPF 15  OLE HENRIKSEN
octinoxate, avobenzone, oxybenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51770-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
PULLULAN (UNII: 8ZQ0AYU1TT)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CALCIUM ASCORBATE (UNII: 183E4W213W)
CHAMOMILE (UNII: FGL3685T2X)
CARROT (UNII: L56Z1JK48B)
AVENA SATIVA LEAF (UNII: 206PI19V7R)
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)
SUCROSE (UNII: C151H8M554)
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
ORANGE (UNII: 5EVU04N5QU)
LEMON (UNII: 24RS0A988O)
LEVOMENOL (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 934 (UNII: Z135WT9208)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHYTIC ACID (UNII: 7IGF0S7R8I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51770-001-02	1 in 1 PACKAGE
1	NDC: 51770-001-01	50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/15/2010

Labeler - Ole Henriksen (133369058)

Registrant - Ole Henriksen (133369058)

Establishment
Name	Address	ID/FEI	Business Operations
HB GORDON MANUFACTURING INC		008328619	manufacture(51770-001)