MESOESTETIC DERMATOLOGICAL SUN PROTECTION BROAD SPECTRUM- avobenzone, benzophenone-3, ensulizole, octocrylene, octinoxate, titanium dioxide cream

mesoestetic DERMATOLOGICAL SUN PROTECTION by

Drug Labeling and Warnings

mesoestetic DERMATOLOGICAL SUN PROTECTION by is a Otc medication manufactured, distributed, or labeled by MESOESTETIC, S.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%

Benzophenone-3  4%

Ensulizole 2%

Octocrylene 6%

Octinoxate 7.5%

Titanium Dioxide 8.94%

PURPOSE

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE

Uses:   -Helps prevent sunburn  -if used as

directed with other sun protections measures (see

Directions), decreases the risk of skin

cancer and early skin aging caused by the

sun.

WARNINGS

Warnings  - For external use only  - Do not

use on damaged or broken skin  -When using

this product keep out of eyes  - Rinse with water to remove

-Stop use and ask a doctor if

rash occurs  -Keep out of each of children  -If

swallowed, get medical help or contact

a Poison Control Center right away.  -Non-water

resistant. Use a water resistant if swimming or sweating

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed,

get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:  -Apply liberally 15 minutes before

sun exposure  -Reapply  -immediately after

towel drying  -At least every 2 hours; Children

under 6 months: ask a doctor  - Sun

Protection Measures:  Spending time in the

sun increases your risk of skin cancer and

early skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum

SPF value of 15 or higher and other

sun protection measures including:  -Limit time

in the sun, especially from 10 a.m. - 2 p.m.

-Wear long-sleeved shirts, pants, hats and sunglasses.

STORAGE AND HANDLING

Other information:  Protect the product in this

container from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients:  Acrylates/C10-30 Alkyl

Acrylate Crosspolymer, Allantoin, Aloe

barbadensis Extract, BHT, Chlorphenesin,

Cyclopentasiloxane, Disodium EDTA,

Ethylhexylglycerin, Fragrance, Glycerin, Glycine,

Isononanoate, Lactic Acid, Manganese Oxide,

Panthenol, Pentylene Glycol, Phenoxyethanol,

Polyamide-5, Polymethylsilsequioxane, PVP,

Serine, Silica, Sodium Chloride, Sodium Lactate,

Sorbitan Oleate, Sorbitol, Tocopheryl Acetate,

Urea, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MESOESTETIC DERMATOLOGICAL SUN PROTECTION  BROAD SPECTRUM
avobenzone, benzophenone-3, ensulizole, octocrylene, octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76450-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.47 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LACTIC ACID (UNII: 33X04XA5AT)
MANGANESE MONOXIDE (UNII: 64J2OA7MH3)
PANTHENOL (UNII: WV9CM0O67Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SERINE (UNII: 452VLY9402)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76450-053-01	1 in 1 CARTON	02/01/2012
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2012

Labeler - MESOESTETIC, S.L. (511046450)

Establishment
Name	Address	ID/FEI	Business Operations
MESOESTETIC, S.L.		511046450	manufacture(76450-053)