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

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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Truth Revealed Super Creme with SPF 15

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)

image of carton

Image of jar label

Ole Henriksen

All skin types/anti-aging

Truth Revealed Super Creme with SPF 15

Net. Wt. 1.7 oz/ 50g

TRUTH REVEALED SUPER CREME SPF 15  OLE HENRIKSEN
octinoxate, avobenzone, oxybenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51770-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51770-001-021 in 1 PACKAGE
1NDC:51770-001-0150 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/15/2010
Labeler - Ole Henriksen (133369058)
Registrant - Ole Henriksen (133369058)
Establishment
NameAddressID/FEIBusiness Operations
HB GORDON MANUFACTURING INC008328619manufacture(51770-001)

Revised: 7/2013
Document Id: 15f4b372-3274-4abb-9a22-89e441d6409f
Set id: e08e0173-9c06-45ff-a884-b89429e91390
Version: 11
Effective Time: 20130708
 
Ole Henriksen