DERMATOLOGICAL SUN PROTECTION- avobenzone, oxybenzone, ensulizole, octocrylene, octinoxate, titanium dioxide lotion

DERMATOLOGICAL SUN PROTECTION by

Drug Labeling and Warnings

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]

Drug Facts

Active Ingredients

Avobenzone 3%

Benzophenone-3 4%

Ensulizole 2%

Octocrylene 6%

Octinoxate 7.5%

Titanium Dioxide 8.94%

Purpose

Sunscreen

Use

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:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe barbadensis Extract, BHT, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragance, Glycerin, Glycine, Hydroxypropyl Methylcellulose, Isononyl Isononanoate, Lactic Acid, Manganese Oxide, Panthenol, Pentylene Glycol, Phenoxyethanol, Polyamide-5, Polymethylsilsesquioxane, PVP, Serine, Silica, Sodium Chloride, Sodium Lactate, Sorbitan Oleate, Sorbitol, Tocopheryl Acetate, Urea, Water.

Package Labeling:

INGREDIENTS AND APPEARANCE

DERMATOLOGICAL SUN PROTECTION 
avobenzone, oxybenzone, ensulizole, octocrylene, octinoxate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76450-051
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	89.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
HYPROMELLOSE, UNSPECIFIED (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)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76450-051-01	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)