Truth Revealed super creme SPF 15 Ole Henriksen

Dosage form: cream
Ingredients: OCTINOXATE 7.5g in 100g, AVOBENZONE 2g in 100g, OXYBENZONE 2g in 100g, OCTOCRYLENE 1.9g in 100g
Labeler: Ole Henriksen
NDC Code: 51770-001

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.

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)

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE2 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE1.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
ALOE VERA LEAF 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
DIMETHICONE 
PALMITOYL TRIPEPTIDE-5 
PULLULAN 
CHONDRUS CRISPUS 
PLUKENETIA VOLUBILIS SEED OIL 
TETRAHEXYLDECYL ASCORBATE 
CALCIUM ASCORBATE 
CHAMOMILE 
CARROT 
AVENA SATIVA LEAF 
VACCINIUM MYRTILLUS LEAF 
SUCROSE 
ACER SACCHARUM BARK/SAP 
ORANGE 
LEMON 
LEVOMENOL 
ALLANTOIN 
ALPHA-TOCOPHEROL ACETATE 
CARBOMER 934 
POLYOXYL 20 CETOSTEARYL ETHER 
AMINOMETHYLPROPANOL 
PHYTIC ACID 
CITRIC ACID MONOHYDRATE 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
1NDC:51770-001-021 JAR 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/FEIOperations
HB GORDON MANUFACTURING INC008328619manufacture(51770-001)

Revised: 07/2013
 
Ole Henriksen

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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