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

MOISTURISING SUN PROTECTION by

Drug Labeling and Warnings

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

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76450-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg  in 1 mL
ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9)	ENZACAMENE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76450-050-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2012

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)

Registrant - Mesoestetic, S.L. (511046450)