MESOESTETIC MOISTURIZING SUN PROTECTION BROAD SPECTRUM FOR NORMAL AND DRY SKINS- avobenzone, ensulizole, enzacamene, octinoxate cream

mesoestetic moisturizing sun protection by

Drug Labeling and Warnings

mesoestetic moisturizing 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%

Ensulizole 2%

Enzacamene 3%

Octinoxate 6%

PURPOSE

Purpose

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:  Allantoin, BHT, Decyl

oleate, Dimethicone, Ethylparaben, Fragrance,

Glycerin, Hydroxypropyl Starch Phosphate,

Imidazolidinyl Urea, Isopropyl Myristate, Lactic

Acid, Methylparaben, Phenoxyethanol, Propylparaben, PVP,

Serine, Sodium

Chloride, Sodium Hydroxide, Sodium Lactate,

Sorbitol, Steareth-2, Steareth-21, Stearyl

Alcohol, Stearyl Dimethicone, TEA-Lactate,

Tocopheryl Acetate, Urea, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MESOESTETIC MOISTURIZING SUN PROTECTION  BROAD SPECTRUM FOR NORMAL AND DRY SKINS
avobenzone, ensulizole, enzacamene, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76450-052
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
ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9)	ENZACAMENE	1.5 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DECYL OLEATE (UNII: ZGR06DO97T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76450-052-01	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(76450-052)