Protect The Truth SPF 50 Ole Henriksen

Dosage form: lotion
Ingredients: AVOBENZONE 3g in 100mL, HOMOSALATE 10g in 100mL, OCTISALATE 5g in 100mL, OCTOCRYLENE 2.7g in 100mL, OXYBENZONE 5g in 100mL
Labeler: Ole Henriksen of Denmark
NDC Code: 51770-222

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.

Protect the Truth SPF 50

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).

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

PROTECT THE TRUTH SPF 50  OLE HENRIKSEN
avobenzone,homosalate, octisalate,octocrylene,oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51770-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE10 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2.7 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLOCTYL SALICYLATE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CETOSTEARYL ALCOHOL 
TETRAHEXYLDECYL ASCORBATE 
CAMELLIA OLEIFERA LEAF 
PULLULAN 
ISOMALT 
GLYCERIN 
DIMETHICONE 
SILICON DIOXIDE 
POLYOXYL 20 CETOSTEARYL ETHER 
XANTHAN GUM 
CITRIC ACID MONOHYDRATE 
SODIUM BENZOATE 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
1NDC:51770-222-021 TUBE in 1 BOX
1NDC:51770-222-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/2011
Labeler - Ole Henriksen of Denmark (133369058)
Registrant -  Ole Henriksen of Denmark (133369058)
Establishment
NameAddressID/FEIOperations
HB Gordon Manufacturing Inc008328619manufacture(51770-222)

Revised: 07/2013
 
Ole Henriksen of Denmark

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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