Label: TRUTH REVEALED SUPER CREME SPF 15 OLE HENRIKSEN- octinoxate, avobenzone, oxybenzone, octocrylene cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 51770-001-01, 51770-001-02 - Packager: Ole Henriksen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active Ingredient Purpose
Octinoxate 7.5% Sunscreen
Avobenzone 2.0% Sunscreen
Oxybenzone 2.0% Sunscreen
Octocrylene 1.9% Sunscreen
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
-
INGREDIENTS AND APPEARANCE
TRUTH REVEALED SUPER CREME SPF 15 OLE HENRIKSEN
octinoxate, avobenzone, oxybenzone, octocrylene creamProduct 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)
