DERMATOLOGICAL SUN PROTECTION

Dosage form: lotion
Ingredients: OCTINOXATE 3.75mL in 50mL, TITANIUM DIOXIDE 3.5mL in 50mL, OCTOCRYLENE 3mL in 50mL, OXYBENZONE 2mL in 50mL, AVOBENZONE 1.75mL in 50mL, ENSULIZOLE 1.5mL in 50mL
Labeler: Mesoestetic, S.L.
NDC Code: 76450-051

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.

Active Ingredients

Drug Facts

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 7%,Octocrylene 6.0%, Benzophenone-3 4.0%, Butyl Methoxydibenzoylmethane 3.5%, Phenybenzimidazole Sulfonic Acid 3.%,

Purpose Section

UVA protection ****  UVB protection SPF 50+    Very high sun protection for sensitive and oily skins

Keep Out Of Reach Of Children

Keep out of reach of children.

Use

Use: Helps to prevent and reduce the damaging effects of the sun's ultraviolet light, including sun burns, premature aging, wrinkles, and reactions associates with sun damage

Warnings

Warnings: Avoid contact with eyes and mucous membranes in case of accidental contact wash thoroughly with water. External use only.

Directions

Directions: Apply the lotion at least half an hour before any exposure to the sun. Apply every six hours.

Inactive Ingredients

Inactive Ingredients: Aqua, Cyclopentasiloxane, Aloe Barbadensis Leaf Extract, Isostearyl Neopentanoate, Sorbitan Isostearate, Polyglyceryl-3-Diisostearate, Capric/Caprylic Triglyceride,  Glycerin, Panthenol, Lauryl Aminopropylglycine, Urea, Sodium Chloride, Lauryl Diethlenediaminoglycine, Serine, Sorbitol,  Alcohol , Sodium Lactate, Lactic Acid, Allantoin, Polymethylsilsesquioxane, Glycine, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Sorbitan Oleate, Hydroxypropylmethylcellulose, Methylisothiazolinone and Methylchloroisothiazolinone, Disodium EDTA, Parfum.

Package Label
MESOESTETIC   DERMATOLOGICAL SUN PROTECTION

UVA protection **** UVB protection SPF 50+

Very high sun protection for sensitive and oily skins

50 ml/ 1.69 fl. oz.

MESOESTETIC

Mesoestetic Pharma Group, s.l.  C/ Tecnologia 25,  08840 - Viladecans (Barcelona)  Tel. +34 902 26 20 31 

  www.mesoestetic.com    made in Spain   1204





DERMATOLOGICAL SUN PROTECTION 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76450-051
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.75 mL  in 50 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.5 mL  in 50 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE3 mL  in 50 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 mL  in 50 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE1.75 mL  in 50 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE1.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
ALOE VERA LEAF 
ISOSTEARYL NEOPENTANOATE 
SORBITAN ISOSTEARATE 
POLYGLYCERYL-3 DIISOSTEARATE 
MEDIUM-CHAIN TRIGLYCERIDES 
GLYCERIN 
PANTHENOL 
LAURYL AMINOPROPYLGLYCINE 
UREA 
SODIUM CHLORIDE 
DODICIN 
SERINE 
SORBITOL 
ALCOHOL 
SODIUM LACTATE 
LACTIC ACID 
ALLANTOIN 
GLYCINE 
ALPHA-TOCOPHEROL ACETATE 
SODIUM OLEATE 
HYPROMELLOSES 
METHYLISOTHIAZOLINONE 
METHYLCHLOROISOTHIAZOLINONE 
EDETATE DISODIUM 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) 
Packaging
#Item CodePackage Description
1NDC:76450-051-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2012
Labeler - Mesoestetic, S.L. (511046450)
Registrant - Mesoestetic, S.L. (511046450)
Establishment
NameAddressID/FEIOperations
Mesoestetic, S.L.511046450manufacture

Revised: 03/2012
 
Mesoestetic, S.L.

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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