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

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.

----------

Drug Facts

Active ingredients

Avobenzone 3%

Ensulizole 2%

Enzacamene 3%

Octinoxate 6%

Purpose

Sunscreen

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 - 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. If swallowed,

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

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.

Other information: Protect the product in this

container from excessive heat and direct sun.

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

copy of label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76450-052-01	1 in 1 CARTON	02/01/2012	04/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2012	04/30/2021

Labeler - MESOESTETIC, S.L. (511046450)

Name	Address	ID/FEI	Business Operations
Establishment
MESOESTETIC, S.L.		511046450	manufacture(76450-052)

Revised: 1/2021

Document Id: ba0aa459-a34a-3abc-e053-2a95a90a526e

Set id: aca12ac3-dc05-4f5b-a2b9-dae942bf856c

Version: 4

Effective Time: 20210129

MESOESTETIC, S.L.