MOISTURISING SUN PROTECTION SPF50- avobenzone, ensulizole, enzacamene, octinoxate lotion 
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.

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MOISTURISING SUN PROTECTION

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 protection 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 reach 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.

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, Fragance, 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.

Package Labeling:

Label2

MOISTURISING SUN PROTECTION  SPF50
avobenzone, ensulizole, enzacamene, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76450-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE20 mg  in 1 mL
ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DECYL OLEATE (UNII: ZGR06DO97T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
IMIDUREA (UNII: M629807ATL)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LACTIC ACID (UNII: 33X04XA5AT)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SERINE (UNII: 452VLY9402)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SORBITOL (UNII: 506T60A25R)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76450-050-0150 mL in 1 TUBE; Type 0: Not a Combination Product02/01/201204/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201204/30/2021
Labeler - Mesoestetic, S.L. (511046450)
Registrant - Mesoestetic, S.L. (511046450)

Revised: 1/2021
 
Mesoestetic, S.L.